Recent blogs:
- 14 November 2011
- Martin Duerden: NICE and hypertension: is the case for change flawed
- 18 August 2011
- Amit Bhargava: GP consortia – an opportunity to refocus medicines management
- 9 May 2011
- Euan Lawson: My least favourite drug: tramadol
- 25 March 2011
- Peter Burrill: Predicting stroke risk in people with AF
- 02 February 2011
- Martin Duerden: What will value-based drug funding mean for GPs?
- 31 January 2011
- Peter Burrill: Statins for primary prevention of cardiovascular disease
- 12 January 2011
- Martin Livingston: Are all antidepressants equal in efficacy?
- 17 December 2010
- Chris Heath: A few laws we could add to Number Ten’s bonfire
- 11 November 2010
- Martin Duerdan: Sidelining NICE – not such a good idea
NICE and hypertension: is the case for change flawed
Dr Martin Duerden questions the rationale behind the recent updated NICE guideline on the management of hypertension
In August 2011 the National Institute for Health and Clinical Excellence (NICE) brought out a guideline that fundamentally changes the way we are advised to diagnose and treat hypertension in England and Wales.1 This guideline is described as an update but in reality is a complete rewrite.
Fundamental changes are appropriate if they are based on solid new evidence. Is this the case with hypertension? It seems not.
Ambulatory blood pressure monitoring
The first issue is the role of ambulatory blood pressure monitoring. If a patient is seen in surgery whose ‘office measurement’ of blood pressure is greater than 140/90mmHg on several readings, then ambulatory blood pressure monitoring becomes the preferred method of diagnosis to guide whether treatment is necessary.
The catch is that this recommendation is based on an assumption that ambulatory monitoring is the ‘gold standard’ to which office measurement and home monitoring should be compared. This is clearly a flawed assumption in the context that all the major drug trials have used office measurement as the starting point for treatment and they show reduced morbidity and overall mortality, ie this is the ‘gold standard’. There is no such evidence for diagnosis based on ambulatory monitoring.
NICE goes further and says that using ambulatory machines in this way will pay for itself as they reduce inappropriate diagnosis. This is based on the machines being something the NHS pays for, but GPs are independent contractors and usually pay to equip their surgeries, so this may not be valid. Who will pay in these austere times?
Ambulatory monitoring has a useful place but GPs may wish to be more judicious and use it selectively in cases where the diagnosis is least clear.
CCBs preferred
The second issue is that of choice of initial drug therapy. Those who have followed the British Hypertension Society and NICE debate over the last decade will be aware of its tortuous history, with drug recommendations changing every few years, and will no doubt be confused.
It all started with recommendations based on a mechanistic model that suggested that angiotensin-modifying drugs (A) or beta-blockers (B) worked better in younger people, but calcium-channel blockers (C) or thiazide diuretics (D) were preferred in people over 55. Apart from very small studies showing some limited class effects on blood pressure lowering, this theory has never been substantiated by large clinical outcome studies with hard end-points (stroke, myocardial infarction, death, etc).
Most evidence-based reviews suggest that what really matters is the ability to lower blood pressure and that overall outcome, based on the balance of risk and harm, is very similar whatever drug is chosen as initial therapy. (An exception was doxazosin in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial – ALLHAT – where an excess of heart failure was seen.)
In the new guideline NICE suggests that the preferred treatment is now an ACE inhibitor or ‘low-cost’ angiotensin-II receptor blocker (currently losartan) in people under 55, and CCBs in those over 55.
Thiazide-like diuretics are only recommended by NICE if CCBs are not suitable as first-line therapy in people aged over 55 years, or black people of African or Caribbean descent of any age. Suggested reasons for CCBs being unsuitable are oedema or intolerance, or evidence or risk of heart failure. Why are CCBs preferred to thiazide-like diuretics when clinical trials, and other indirect analyses, do not show differences in overall outcome?
Reading the NICE deliberations shows that this recommendation is based on a health economic analysis comparing risks and benefits of CCBs and thiazides. The main analysis compares the lowest-cost CCB, amlodipine, with the low-cost thiazide in common use in the UK, bendroflumethiazide. The risks of oedema and heart failure with CCBs are balanced against the risks of emergent diabetes with thiazides. CCBs appear more cost-effective, but only ust. Is such decision-making robust enough to change practice in this way?
Chlortalidone – an odd choice?
Perhaps the most surprising recommendation is the choice of thiazide. The NICE guideline says that chlortalidone 12.5–25mg once daily or indapamide once daily are now preferred to bendroflumethiazide or hydrochlorothiazide. Again, looking at their deliberations the guideline group base this recommendation on the ‘more contemporary’ drug trials for chlortalidone and indapamide, with concerns that the other thiazides might not give the same overall benefit. This seems perverse as the health economic argument is based on accepting a class effect.
Hydrochlorothiazide is only available in various combination products, so not using this is no big deal. However a pressing question, and maybe one that most discredits the guideline, is how can chlortalidone be prescribed at the recommended evidence-based doses in the UK when the only ‘monotherapy’ preparation currently available is chlortalidone 50mg tablets (Hygroton)?
Reference
1. National Institute for Health and Clinical Excellence. Hypertension. Clinical management of primary hypertension in adults. Clinical guideline 127. August 2011.
Declaration of interests
None declared.
Dr Duerden is a GP and assistant medical director for Betsi Cadwaladr University Health Board, North Wales, and honorary senior lecturer at Cardiff and Bangor universities; he sits on a NICE technology appraisal committee
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GP consortia – an opportunity to refocus medicines management
Dr Amit Bhargava believes that the emergence of GP consortia provide an opportunity to refocus prescribing on quality of care
Older GPs will remember being discouraged from prescribing Zantac (ranitidine) because the newly off-patent cimetidine was cheaper, while concerns that adverse effects were more common with cimetidine were brushed aside. When ranitidine’s patent expired, it became the preferred H2-antagonist again.
Keeping patients well
Implementation of medicines management has for many years been driven by the desire of PCTs to reduce prescribing costs – in effect, auditing GP prescribing. Though this form of medicines management did see the introduction of useful changes and provided valuable savings on the drugs bill – promoting generic prescribing, cutting variation in prescribing, reducing inappropriate use of antibiotics, avoiding drugs of limited clinical value – this focus on the financial aspects of prescribing was a missed opportunity to look at the whole care pathway.
The primary objective of medicines management should be keeping people well, out of hospital, functional and independent. This means more than prescribing to meet targets for blood pressure and blood glucose: it means asking whether it is right to pursue surrogate end-points to the extent that patients’ lives are blighted by adverse effects. It means stopping patients becoming dependent on carers.
The use of newer agents for type 2 diabetes is a case in point: they have increased prescribing costs, true, but they have allowed many patients to control their blood glucose without recourse to insulin and avoided the need for all the training, monitoring and support that goes with it. Patients may also have been able to avoid adverse life events, eg loss of employment for an HGV driver.
A new opportunity
Medicines management should be about striking the right balance between patient-focused outcomes, commissioning needs, cost and clinical effectiveness. The emergence of GP consortia provides the opportunity to realise its full potential. PCTs are accountable bodies led by lay members and executives but few clinicians; their priorities are largely financial balance and good contracting.
By contrast, GP consortia will be led by front-line clinicians, population focused and locally accountable. Their driver will be optimising the health of the population they serve: keeping patients out of hospital and at work by investing in treatments for chronic illness and tackling social determinants of ill-health while living within available resources.
Pharmacists will continue to be major players in delivering medicines management. Their assessment of evidence and role in containing prescribing costs will still be essential, but they will need to extend their skills to optimise patient pathways rather than balance sheets. This shift of priorities has widespread support among health professionals, and a multidisciplinary team approach seems likely.
GPs know that investing in more expensive medicines can sometimes be justified by the health gain and longer-term savings and managing the whole commissioned pathway, an approach that short-term, financially-focused medicines management will not deliver. GP-led commissioning is an important opportunity to develop patient-focused medicines management. GPs are in it for the long haul: they have a greater investment in the consequences of their decisions than managers, whose focus is balancing the end-of-year budget. GP consortia will therefore want to adopt a rational, long-term perspective on outcomes.
If we do not grasp the nettle and refocus prescribing on the quality of care, medicines management will again become a nonclinical activity.
Declaration of interests
None declared.
Dr Bhargava is a GP in Crawley, West Sussex, chair of the Crawley Commissioning Consortia and national co-lead for the NHS Alliance Clinical Commissioning Federation
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My least favourite drug: tramadol
Dr Euan Lawson explains why he grinds his teeth when prescribing tramadol
We all have drugs we don’t like prescribing. I don’t mean the mild prickly irritation we feel when giving out medications where we know the benefits are marginal – I mean the kind of medication that makes you grind your teeth as the scrip prints and where you gouge your signature into the desk as you sign it. For me, that drug is tramadol.
My local hospital seems to be obsessed with it. It is thrown around with gay abandon by the junior doctors. Pain ladders seem to be utterly disregarded and I am regularly regaled with tales of little old ladies and their tramadol trip.
Most recently I met one lady who had been on it for several weeks but then suffered a clear ‘rattle’, an opiate withdrawal, when she stopped. I seem to be spending my life running into people who are either abusing or are being abused by tramadol.
It has some pretty peculiar narcotic properties. Tramadol is an incredibly popular drug of abuse in prisons. It has pulled off the trick of providing all the desired intoxicating effects of an opioid without the inconvenient side-effect of showing up in the urine.
All prisoners have to have mandatory urine drug screens, and prisoners with serious opiate habits keep getting extra days on their sentences for positive tests.
Tramadol will relieve opiate withdrawal if the heroin supply drops off, it will get you conveniently smashed if you want, and it can’t be detected by the authorities. It’s an absolute wonder drug.
I think that one of the underlying attractions of tramadol is that it taps into a fear of morphine. Morphine has been demonised; it is now regarded as fundamentally evil, even an instrument of death in the wrong hands, and it is shunned by the medical profession. Patients will often recoil in horror if you suggest morphine for their pain.
They won’t bat an eyelid at tramadol or codeine, even when I explain that codeine has its effect because it is metabolised to morphine in the liver. If I insisted on offering morphine I’d probably be reported to the GMC.
Tramadol represents a modern approach to medications – a belief that there is no drug that can’t be improved with a tweak here and a tweak there. We need a far more honest approach to analgesia than the one tramadol represents.
Dr Lawson is a GP in Cumbria
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Predicting stroke risk in people with AF
Peter Burrill examines the CHADS2 and CHA2DS2-VASc risk stratification tools
Patients with AF have a substantial risk of stroke, which is modified by the presence or absence of several risk factors. These risk factors have been used to develop thromboembolic risk stratification schemes. The most commonly used scheme is the CHADS2, ie Congestive heart failure, Hypertension, Age ≥75, Diabetes mellitus, previous Stroke/TIA (double risk weight).
A paper published in 2010 introduced the Birmingham 2009 schema – otherwise known as CHA2DS2-VASc (see Table 1) – risk stratification tool.1 The authors concluded that CHA2DS2-VASc provides some improvement in predictive value for thromboembolism over the CHADS2 schema, with low event rates in low-risk subjects and the classification of only a small proportion of subjects into the intermediate risk category. They suggest that this schema could improve our approach to stroke risk stratification in patients with AF.
| Risk factor |
Score |
| Congestive HF/LV dysfunction | 1 |
| Hypertension | 1 |
| Age ≥75 years | 2 |
| Diabetes mellitus | 1 |
| Stroke/TIA/thromboembolism | 2 |
| Vascular disease (MI, PAD, or aortic plaque) | 1 |
| Age 65–74 years | 1 |
| Sex category (ie female gender) | 1 |
Table 1. The CHA2DS2-VASc schema; scores range from 0 to 9.1
CHADS2 vs CHA2DS2-VASc
A recently published study has compared the capability of CHADS2 and CHA2DS2-VASc to predict thromboembolism.2 This was a registry-based cohort study using nationwide data on all patients admitted to hospital with atrial fibrillation (AF) in Denmark in the period 1997–2006.
In patients at ‘low-risk’ (score = 0), the rate of thromboembolism per 100 person years was 1.67 (95% CI 1.47–1.89) with CHADS2 and 0.78 (0.58–1.04) with CHA2DS2-VASc at one year’s follow-up. In patients at ‘intermediate risk’ (score = 1), this rate was 4.75 (4.45 to 5.07) with CHADS2 and 2.01 (1.70 to 2.36) with CHA2DS2-VASc. In the ‘high risk’ (score ≥2) category the rates were 12.27 (11.84 to 12.71) and 8.82 (8.55 to 9.09), respectively. The authors conclude that CHA2DS2-VASc performed better than CHADS2 in predicting patients at high risk, and those categorised on low risk by CHA2DS2-VASc were truly at low risk for thromboembolism.
Is CHA2DS2-VASc the future?
Should we now adopt CHA2DS2-VASc as our risk assessment tool of choice? As the editorial points out, if this were adopted most people with AF would be offered anticoagulation.3 Essentially the only people who meet the ‘truly low risk’ category are men aged under 65.3 This has not only implications for increased use of warfarin but also for possible increased use of dabigatran (Pradaxa) when it receives the appropriate licence.
New European guidelines on AF have moved to the CHA2DS2-VASc schema.4 Is this system too complicated for GPs to use in a busy surgery? The GRASP-AF (Guidance on Risk Assessment and Stroke Prevention for Atrial Fibrillation)5 tool uses CHADS2 to identify patients at high stroke risk who are not receiving warfarin and who would benefit from a review to assess the issue of anticoagulation. Perhaps we should stick with the familiar CHADS2 system and concentrate on appropriately treating high-risk patients as many appear to be undertreated?6
References
1. Lip GYH, et al. CHEST 2010; 137:263–72
2. Olesen JB, et al. BMJ 2011;342:d124
3. Fang MC. BMJ 2011;342:d530
4. Hunter RJ, et al. BMJ 2011;342:d897
5. NHS Improvement. Guidance on Risk Assessment and Stroke Prevention for Atrial Fibrillation. www.improvement.nhs.uk/graspaf/
6. Cowan C, et al. BMJ 2011; 342: 456
Peter Burrill is specialist pharmaceutical adviser for public health, NHS Derbyshire County
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What will value-based drug funding mean for GPs?
Martin Duerden discusses the implication of the Government's proposed new pricing system to replace the Pharmaceutical Price Regulation Scheme
The new proposals for value-based drug pricing seem far removed from the concerns of general practice today. It would seem sensible that the NHS only pays what it thinks is a price worth paying for drugs and one would presume that this is the case already.
Instead we have an arcane system devised in 1957 that enables drug companies to set their own prices for drugs but limits the profit they can make from the NHS on the whole. These profits, with tax breaks for research and development and marketing, do seem generous in our austere times and the system cries out for reform.
However, the reform proposed seems even more convoluted and bizarre. For new drugs the Government is consulting on a system they intend to put in place in 2014, called ‘value-based pricing’. Unfortunately the system proposed does not bear much relationship to value for money and will put GPs in an invidious and difficult place.
Devolved decision making
Probably the first thing that GPs need to know is that as a result of these proposals the National Institute for Health and Clinical Excellence (NICE) will no longer advise on which treatments should or should not be funded by the NHS. Instead, in England, this will be their decision, or rather those of the GP Commissioning Consortium they belong to.
An NHS price for new drugs in the UK will be based on an assessment of their value at launch, based on their potential for clinical benefit, and ‘signed off’ by the Health Minister for England. This means that GPs may have to directly advise patients that they cannot have a treatment because their Consortium will not or cannot afford to pay for it.
At present GPs are removed from these decisions as NICE (and faceless bureaucrats like myself) can be blamed. This will be even more difficult as it is likely decisions will vary from one Consortium to another undermining recent efforts to remove ‘post-code prescribing’ and create equity in the NHS.
With the removal of practice boundaries described in the Government White Paper, ironically called Equity and Excellence: liberating the NHS, patients will now be free to move practices to seek funding from other Consortia. The pressures in the system will be even more intense given the unprecedented major restrictions on funding due to cuts in public spending.
Added value?
There are many other criticisms and it is difficult to see how the proposals for value-based drug pricing will add value. The process seems complex and will require detailed clinical data and health economic analyses to be available at the time of marketing authorisation (‘licence’) being granted. This kind of detail is rarely available, although arguably it should be, and this absence may delay availability of innovative treatments in the UK.
Furthermore, drug companies are multinational and usually set prices based on the global economy so they may not be too worried about engaging in complex negotiations with the NHS, which only represents 3.5 per cent of the total global market; they may simply decide not to engage or market in the UK. They may also decide to no longer invest in research and development in the UK.
The worst-case scenario is that faced with this reality and in order to make the UK more drug company friendly the Government bows to pressure and the new system results in an overall increase in drug prices to the NHS. We can’t afford this and under the reforms and these new drug pricing proposals GPs will not only be the gatekeepers they will also hold the purse strings.
The Department of Health is consulting on its value-based pricing proposals until 17 March 2011. What are your views: respond to this Blog.
Dr Duerden is a GP and Acting Medical Director for Betsi Cadwaladr University Health Board, North Wales, and honorary senior lecturer at Cardiff and Bangor Universities. He sits on a NICE Technology Appraisal Committee
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Statins for primary prevention of cardiovascular disease
Peter Burrill discusses the risk and benefit of prescribing statins for the primary prevention of cardiovascular disease
On 19 January 2011 the Daily Mail had a headline ‘Statins “may cause loss of memory and depression”’.1 The article states ‘Cholesterol-lowering pills taken by millions of Britons may cause memory loss and depression, researchers warn. They say not enough is known about the level of harm posed by statins, prescribed to prevent heart disease and strokes’ and ‘They warn statins should only be prescribed to those with heart disease, or who have suffered the condition in the past. Researchers warn that unless a patient is at high risk of suffering a heart attack or stroke, statins may cause more harm than good’. Should patients ditch their statins?
The Daily Mail was reporting the publication of a Cochrane review ‘Statins for the primary prevention of cardiovascular disease’.2 From the plain language summary: ‘All cause mortality, coronary heart disease and stroke events were reduced with the use of statins as was the need for revascularisations. Statin treatment reduced blood cholesterol. Taking statins did not increase the risk of adverse effects such as cancer and few trials reported on costs or quality of life. This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.’ Mmmm… not quite the impression you get from the Daily Mail.
Assessing the risks and benefits
All drugs come with risks as well as benefits. When does the risk/benefit ratio cross the line into good for the individual and for the population? The national policy for primary prevention is to offer (not automatically prescribe) a statin to someone if their individual risk of having a cardiovascular (CV) event is 20 per cent or more over a 10-year period. At this risk level 80 per cent will not have a CV event, ie do not need a statin. However, we do not know who these people are so everyone has to take a statin.
For the 20 per cent who will have an event, taking a statin will only reduce the risk not eliminate it. With a 30 per cent relative risk reduction, six people will have their event prevented. The other 14 will still have their event despite taking a statin. So 100 people take a statin for primary prevention at the 20 per cent 10-year risk level and only six will benefit. But everyone who takes a statin runs the risk of the adverse effects. Would you take it?
For information on the adverse effects of statins, a recent paper on the unintended effects of statins in the BMJ is useful.3 The authors calculate that based on the 20 per cent threshold for cardiovascular risk, for women the number needed to treat (NNT) with any statin to prevent one case of cardiovascular disease over five years was 37 (95% CI 27–64) and for men 33 (95% CI 24–57). In women the number needed to harm (NNH) for an additional case of acute renal failure over five years was 434 (95% CI 284–783), of moderate or severe myopathy was 259 (95% CI 186–375), of moderate or severe liver dysfunction was 136 (95% CI 109–175), and of cataract was 33 (28–38).
Overall, the NNHs for men were similar to those for women, except for myopathy where the NNH was 91 (95% CI 74–112). As the accompanying editorial4 says: ‘We should neither overstate the size of the benefit of statins, nor exaggerate their side effects. Our understanding of the intended and unintended effects of statins is still incomplete and will continue to evolve.’
Patient choice
In the short term, for true primary prevention, the benefit appears small. In the long term, although sincere advocates on both sides will try to convince us otherwise, we really must admit that we do not know. In the spirit of concordance, the decision to commence a statin should be a joint one between the health professional and the patient. The patient needs the pros and cons explained to them in a way that they can understand. Smiley face charts can help to do that (see www.nntonline.net and www.npc.co.uk/prescribers/index.htm).
They may well choose to say ‘no thanks’ when they understand the facts and there is nothing wrong with that. If you are concerned then record the discussion and decision in their notes. Personally, I wouldn’t take it. If you and the patient decide that a statin is the right thing then make sure it is simvastatin 40mg, with no target chasing. As the NPC points out: ‘NICE lipid modification guidance explicitly sets no lipid targets that patients are expected to achieve, for either primary or secondary prevention’.5
References
1. Statins ‘may cause loss of memory and depression’. Daily Mail 19 January 2011. www.dailymail.co.uk/health/article-1348435/Statins-cause-loss-memory-depression.html
2. Taylor F, et al. Statins for the primary prevention of cardiovascular disease (Review). Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4.
3. Hippisley-Cox J, et al. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ 2010;340:c2197.
4. Alsheikh-Ali AA, et al. Balancing the intended and unintended effects of statins. BMJ 2010;340:c2240.
5. National Prescribing Centre. Shifting views on lipid lowering therapy. www.npci.org.uk/blog/?=1780.
Peter Burrill is specialist pharmaceutical adviser for public health, NHS Derbyshire County
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Comments
Excellent Blog. Very helpful to give figures that we can then give to patients, to allow them to make a choice. Many people when faced with a NNT of 30–40 and a NNH of ≥90(depending on the adverse event) will be reluctant to take statins, but some will consider it worthwhile. It would be interesting to know the NNTs and NNHs associated with decisions people make in their everyday life aimed at trying to live longer healthy lives. Examples might include driving a high safety-rated car, exercise, eating organic food. When considered alongside statins, how would these NNTs and NNHs (eg opportunity costs) stack up?
– Prof Tony Avery, consultant editor, Prescriber
Are all antidepressants equal in efficacy?
Martin Livingston responds to the recent systematic review of reboxetine and gives his view on the equality of antidepressants
The Eyding et al. paper cited in the InfoPOEM (Prescriber 2011;22 issue 1:25) is of interest to prescribers for several reasons.1 Firstly, it illustrates the importance of having access to all the data on drug development and research, including both positive and negative outcome studies, when evaluating the efficacy and tolerability of a treatment.
Secondly, it is an important challenge to the commonly held belief that all antidepressants are equally effective and that the choice of antidepressant depends on tolerability or characteristics of the drug other than efficacy in depression, eg whether sedation is a desirable action or not.
Not only was reboxetine, a noradrenalin re-uptake inhibiting drug, shown to be less effective than SSRIs in the unpublished data, but it was no more effective than placebo and less well tolerated than SSRIs and placebo. The published studies, the paper implied, did not accurately represent the available data on this medication.
Cipriani et al. meta-analysis
In a sense the message from the Eyding paper comes as no surprise. A carefully conducted meta-analysis2 examined the efficacy and 'acceptability' of 12 antidepressants: bupropion, citalopram, duloxetine (Cymbalta), escitalopram (Cipralex), fluoxetine, fluvoxamine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine. It will immediately be evident that this synthesis is limited in scope. For example, no tricyclic was included – lofepramine, relatively safe in overdose, would have been a useful addition. What emerged from the meta-analysis was that four antidepressants were more effective: escitalopram, mirtazapine, sertraline and venlafaxine. Of these four, escitalopram and sertraline were better tolerated and reboxetine emerged as the least effective antidepressant of the 12 studied.
The meta-analysis was considered important enough to merit an editorial comment3 which appeared in the same issue of The Lancet. More contentious than the antidepressant efficacy pecking order, however, is the conclusion of Cipriani et al. that their analysis has relevance for our prescribing practice. The studies reviewed provide a short-term window on depression (usually 6-12 weeks), by way of contrast with the more usual long-term prescription of antidepressants in clinical practice.
Switching antidepressant
Odds ratios for efficacy of the four most effective antidepressants compared with the rest, with the exception of reboxetine, are in the range of 1.22 to 1.44 equivalent to a numbers needed to treat (NNT) in the range of 12–20. Compared with reboxetine, the NNT are in the range of 6–7.
Consider the response of a depressed patient, refractory to treatment, on being offered a switch to one of the four more effective drugs from any of the other eight, except reboxetine. If advised, accurately, that they have a 1 in 12 to 1 in 20 chance of responding to the change in antidepressant would our patient feel that the switch was worth a try? Would you? A switch from reboxetine to escitalopram, mirtazapine, sertraline or venlafaxine does, of course, carry a higher likelihood of success. Here our nonresponder has between a one in six and a one in seven chance of responding.
Conclusion
In reality there is a small chance of a benefit in prescribing from the list of four 'superior' antidepressants over the other seven (excluding reboxetine), of which escitalopram and sertraline offer better tolerability, and the evidence suggests there is no good reason to prescribe reboxetine as a monotherapy in depression. But might it be a useful add-on with an SSRI, in effect creating a variable serotonin and noradrenalin re-uptake inhibiting combination?
References
1. Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor trials. BMJ 2010;341:c4737.
2. Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple treatments meta-analysis. Lancet 2009;373:746–58.
3. Parikh SV. Antidepressants are not all created equal. Lancet 2009;373:700–1.
Dr Livingston is consultant psychiatrist and honorary senior clinical lecturer, Southern General Hospital, Glasgow
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A few laws we could add to Number Ten’s bonfire
Chris Heath believes over-regulation in reaction to serious malpractice harms the very people it is intended to protect.
With the change of government, Ten Downing Street set up an interesting web site ('Your Freedom'; now closed and archived – see http://yourfreedom.hmg.gov.uk/). This was intended to encourage the overregulated people of Britain to suggest laws that could be dumped. Think of the changes that have been imposed on we GPs over the last few years and I am pretty sure you will come up with several that could be dispensed with. So what could be removed?
Appraisal
The endless screening and recording imposed by the new contract has turned us into clerks, administrative assistants. More interested in the computer than the patient. So I say dump Quality and Outcomes Framework (QOF). The Appraisal process can sometimes be productive, mentoring and informative for the appraisee but it is definitely NOT a way of rooting out the sort of psychopath whose serial murders prompted it. It costs a fortune and is largely superfluous. So dump Appraisal.
Controlled drugs
But the MOST harmful regulations that we must remove have come in almost unnoticed and have the potential to cause huge suffering. I mean those new laws covering the use of controlled drugs by GPs. I was shocked (and I am not easily shocked) to discover one unexpected effect of these burdensome regulations.
I have believed for 30 years that one of the most useful and important drugs I had at my disposal was diamorphine. It relieves pain, distress, dyspnoea, it is the treatment of choice in several clinical situations and is the cancer sufferer’s friend. I hope to God my GP has it if and when I am dying of cancer, respiratory failure, motor neurone disease, etc. Yes it can be abused – and lawyers constantly threaten us with the consequences of its inappropriate use. But diamorphine and pethidine injections were always the drugs that I felt I could do the most good with – if potentially the most harm.
The unforeseen result of the new regulations is that fewer than a third of my partners now carry these effective systemic pain killers in their bags. They have decided that severe pain, renal and biliary colic, broken bones, traumatic accidents, the pain of terminal illness and myocardial pain are rare enough for them not to be bothered with the bureaucracy and inconvenience now attached to carrying effective analgesics.
This is the 'Law of Unforeseen Consequences'. A political and legal solution to a vanishingly rare risk has led to potential harm on a grand scale affecting the very people that the new laws were designed to protect. Before an evening meeting at a local post graduate centre I asked all the other GPs how many of them carried pethidine or diamorphine. It was unbelievable to me that I was the only doctor still carrying these drugs. What a change in so short a time.
I believe that all those doctors and most of my partners are now letting their patients down. They have become moral cowards and made themselves unprepared for a life in real general medical practice. Their justification is that they can call the ambulance rather than deal with these situations personally. They think they don’t need to carry strong painkillers. This is make believe. The ambulance service is overwhelmed and you can’t walk away from a patient in pain.
I had a man in his 40s consult during afternoon surgery three weeks ago. He had chest pain and it was clear he was having an infarction. I phoned for a blue light ambulance and it took 30 minutes to come. Thank God I had the drugs to relieve his pain and distress.
It appears most of my colleagues would only have been able to wring their hands and offer sympathy. They are fearful that patients are now intrinsically suspicious of their doctors, that PCT administrators and compensation lawyers are falling over themselves to pillory GPs who are just trying to do their job.
Where is our professional courage? Where is the ethos that the patient’s needs are paramount? I am ashamed. This is professional paranoia leading to a collective moral cowardice. Certainly the new and cumbersome regulations have resulted in a profound and so far unrealised change in the role of family doctors and an abrogation of what every patient has the right to expect from us. The treatment of what we all fear most, severe pain.
Why must we all be tarred with the same brush as Shipman? He was a psychopath. The rest of us aren’t. If Shipman had been a carpenter who stabbed to death a series of his customers, would the Government introduce new laws to regiment the obtaining, owning, storage, use, supervision and disposal of screwdrivers? I know I am stretching the analogy a bit too far, but strong pain killers ARE the tools of our trade. Used for centuries responsibly by the majority of us and without which we cannot do the job we are paid for.
Conclusion
We are all desperately sorry for the victims of Shipman and their relatives. We are shocked that one of our number cruelly abused the trust of his patients and the expectations of his colleagues in this way.
But it is clear that the onerous new rules concerning controlled drugs and that other legal changes – the expensive system of appraisal, the new intrusive requirements of the part 2 cremation form, etc – all laws in reaction to Shipman, would simply not have detected or prevented him from committing his serial murders.
And what is worse, these new laws just make it harder for the rest of us to care for patients properly. Surely these above all are new laws that need to be removed?
Dr Chris Heath GP, Horsham
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Sidelining NICE – not such a good idea
Martin Duerden is not convinced that the decision to take away NICE's decision making power is such a good idea. In fact it could lead to confusion and a 'practice' prescribing lottery.
The last few weeks have been quite distressing and very confusing for those of us tasked with making the best use of our limited resources to provide healthcare for our local populations. The coalition government are starting to put flesh on the bones of their white paper on the future shape of the NHS in England and are beginning to describe how cancer drugs will be provided, alongside their ideas for the future role of the National Institute for Health and Clinical Excellence (NICE). The cancer drugs fund seems perverse enough as it is and suggests that drug companies can charge what they want for drugs of limited clinical value, continue to persuade the public and the media that they are wonder drugs and don’t need to worry about NICE appraisals.
Some see this as a success, ‘In a stunning victory for patients – following a campaign by the Daily Mail – the controversial organisation NICE will be stripped of its powers to ban drugs on the Health Service’ (Daily Mail 1st November 2010). Many people in my position, who are experienced at appraising these treatments, are concerned by the serious inability of some of these drugs to improve outcome. We struggle to see how this will bring benefit to many of our patients when we could do much more with the same money to provide services which have much greater potential for good. The reality of the government’s comprehensive spending review is that we will have to cut these services and other patients will suffer.
This emasculating of NICE may not be as definitive as the Daily Mail and the drug industry predicts, or would like, as NICE will continue to give guidance via Technology Appraisals on treatments that the NHSs in England and Wales should or should not provide, based on estimates of cost effectiveness, until 2014. At this point a system of value-based-pricing will be introduced that is intended to reduce the price of drugs if they do not do much. However, it is difficult to believe that this process will be timely or efficient.
The real problem for GPs in England is that they will be responsible for deciding who gets these treatments in the future. They will have to face individual patients and cannot hide behind ‘faceless bureaucrats’ such as myself (or NICE) when they deny access to these drugs to people who wrongly perceive them as ‘life saving’. What if the neighbouring GP commissioning group are allowing the same treatment? How will GP commissioners work closely with their patients at the same time as needing to make best use of limited funds? Individual need versus distributive justice: I don’t envy them this task.
Dr Duerden is a GP and assistant medical director (Primary Care), Conwy and Denbighshire, Betsi Cadwaladr University Health Board for North Wales, and honorary senior lecturer, Cardiff University; he sits on a NICE Technology Appraisal Committee
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Comments
I agree with the points raised in this blog. NICE plays an important role. As a medic working both as a GP and a pharmaceutical physician I can see how pharma companies are finding it increasingly difficult to pull together the masses of data needed to distinguish their products from each other, and how as a GP it can be difficult to keep abreast of all the relevant literature ourselves. NICE evaluates the data on our behalf, and acts as the impartial assessor, saving individual prescribers the time and effort involved, reviewing data that may not necessarily enter the public domain, and creating a system that is fair. Other countries have similar bodies making reimbursement decisions, often following decisions made by our own highly regarded system. Has this "sidelining" decision been consulted across Europe?
– Anonymous GP
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