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| Science & the Environment | |
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| 13/07/04 | Good News on Adverse Events? By Edward Teague |
1 in 10 patents entering NHS hospitals will experience an “adverse event”, and 1 in a 100 will die as a consequence writes the Editor of the British Medical Journal (BMJ) this week. The unwillingness of the medical establishment, consultants, doctors, nursing staff, pharma companies and the NHS managing bodies, trusts and their elected and un-elected representatives to examine this dark secret within the health services is understandable, if regrettable. It is even more regrettable that it is only after 60 years of the National and “free at the point of delivery” Health Service (NHS), which was apparently, until recently, “the envy of the world” are the “adverse” effects of hospital treatment being identified and studied. Especially since Ivan Illych in the early 1970's in his book Medical Nemesis alerted the world to the problems of iatrogenic illness, that is, illness caused by medical treatment. In the UK efforts to quantify and cost these effects in monetary and wasted use of staff, time and resources. Only now are we shuffling towards framing sensible, rational plans to deal with these skeletons in the medical cupboard. Unlike say, the Netherlands where constant monitoring, high levels of isolation of affected patients and rigorous controls have almost completely removed the problem from hospital wards of Hospital Acquired Infections (HAI), Medical mistakes, misdemeanours, misunderstandings and resulting confusions and cockups are an apparently irredeemable consequence of organisations such as the NHS, the biggest employer in Europe. Plenty of studies on both sides of the Atlantic have shown the varying extent of dishonesty, incompetence and plain stupidity, the costs of which, both in health and money are exacerbated by the introduction of the legal process. This has led to excessive litigation, overpaid greedy lawyers, fed and funded by obtuse thick skinned and bone headed bureaucrats unwilling to accept the realities of the world, anxious to both conceal and cover-up their organisation's mistakes and errors. Their medical colleagues meanwhile have continued to peddle the popular myths of modern medical practice with it's much publicized store of hi-tech wizardry, golden bullets and glamorous “brilliant” surgeons, fresh from their glitzy tours of the TV studios. Staphylococcus infections, have been present for decades in UK hospitals, they frequently accelerated death for patients with terminal conditions, and consequently obtained the medically neutral and apparently benevolent description as “the old man's friend”. The problem was trivialised and ignored, a factor affected by changes in hospital management more anxious to control costs than disease. Resistant Staphylococcal aureus strains emerged (MRSA). The increasing prevalence of these mutants resulted from widespread over prescribing, by GP's, to pacify and placate over anxious mothers, often for minor childhood but troublesome viral infections for which treatment with antibiotics is pointless. Strains appeared in hospitals world wide, often resulting from the use of massive doses of antibiotics, to control wound infections, increasingly because of the use of novel and extensive invasive surgical procedures, especially organ transplants, bio-mechanical implants and more recently the widespread use of very much improved dialysis methods as well as unnecessary catheterization of incontinent patients to relieve nursing care, reduce bed changes and control costs. There is broad agreement that 50,000 patients are affected each year in the UK with 5,000 deaths in hospital (at least) from HAI (not including deaths after discharge which are unknown but must occur). Of course patients discharged who subsequently need to return to hospital for treatment are a “new patient” and thus boost patients throughput, thus, really discharge provides the benefit of improved patient throughput and reducing the incidence of recorded HAI. The Netherlands, our Health Minister has now discovered have largely overcome this problem with constant monitoring, high levels of isolation of affected patients and rigorous controls. Apparently we will shortly be flying in experts to resolve the problems of neglect and the electoral consequences of a sceptical population of NHS users. To MRSA must now be added Multiple Drug Resistant TB (MDRTB) of which there have been (to date) a few isolated outbreaks and deaths which will increase due to in an increase hospitalised HIV / TB patients, especially of infected immigrants from Africa and increasingly Eastern Europe and the new EU states such as Estonia and Slovakia. There is reason to believe that MDRTB is where MRSA was 20/30 years ago – therefore effective prompt action is essential. Care costs for a single patient of MDRTB can be in the hundreds of thousands of pounds and an outbreak in millions. Studies in the developed world have now clearly identified the costs and consequences, of MRSA. In the UK, the National Audit Office (NAO), an organisation with no direct health responsibilities it must be noted, have been instrumental in driving changes, essentially for economic reasons. Paradoxically, as a result of more rigorous definitions, improved reporting, and defined responsibilities for infection control in hospitals it is evident that the problem is larger and more pervasive in UK hospitals than initial studies had indicated. Unfortunately the story currently promoted is that the anxious patients wringing their hands in grief have been replaced by nursing staffs educated in hand washing. Probably if there was a Royal College of Hospital Cleaners, anxious to protect their members interests, such a simple solution identifying the prime cause of sloppy cleaning, might not be promoted with such zeal. Miss Claire Rayner ex-nurse and popular gadfly blames non-English speaking cleaners (Radio 5 Live 11/7/) – she will no doubt be horrified to be treated by a consultant from the new member EU states who has not been required to pass the language examinations which apply to consultants from our Commonwealth cousins. A DRUGS DOWNER IN LIVERPOOL Now Dr Munir Pirmohamed and colleagues in Liverpool report the consequences of admitting patients suffering from adverse drug reactions (ADR) in 2 Liverpool hospitals (BMJ Vol 329 3.7.04. p. 15-19). They studied 18,820 patients admitted over a 6 month period in 2001 over 16 years old, excluding all patients with deliberate or intentional overdosing and women with obstetric or gynaecological problems, a total of 1225 admissions. This was the largest such study undertaken in the UK and showed that ;
Besides the unsurprising call for more research, the authors conclude that it is incumbent on primary care prescribers to use the lowest dose necessary to achieve results, they identify evidence from others, that deaths related to aspirin (the cause of most problems and deaths of ADRs in the study, directly and in association with other drugs) could be reduced by 30% with a standard low dose of 75mg. Funded by the Medicines and Healthcare Products Regulatory Agency (MHRA formerly Medicines Control Agency) the study highlights the needs for urgent action to reduce the burden on the NHS (presumably in money, wasted resource, and opportunity cost, and customer satisfaction), not to mention the anguish to patients and their families of illness, hospitalization and death. It is very good news that several of the authors sit on bodies and authorities who can pursue more research and effectively ensure that the necessary and urgent action is taken. Let us not forget that the initial report quantifying the costs of HAI from the NAO was published over five years ago and it is only this week that the Health Minister has announced the comprehensive plans for action. Interestingly the authors of this study, in describing their methods of statistical analysis state that, “A P value <0.05 was regarded as being significant”. A recent study in online journal BMC Medical research Methodology by Spanish authors Garca-Berthou and Alcarez of papers in the BMJ and Nature showed the belief in the widely used criterion of <0.05 as a measure of “statistical significance”. As any fool knows, the concept of “significance” was introduced over 70 years ago by R.A. Fisher in attempting to provide some sort of numerical value to the significance of outcomes. Just as Bayes ( the first ever actuary for the insurance industry – he helped found the Equitable Life) gave numerical values to probability, the results of which misapplication, identified by Lancelot Hogben in the 1950's, (as Hogben foretold) has resulted in the impoverishment of not only the holders of pensions and endowments with Equitable Life but with every Life and Pensions company. Essentially, as most basic textbooks explain, the test for “significance” is based on giving a probability of your results, which are statistically random events, being the same as results of another set being produced in as random a fashion. Such a figure of “significance” does not add (or subtract) the validity or legitimacy of the results but just provides a frame of reference for evaluation. Pension holders are discovering that the random events generated by plunging stock markets, corrupt financiers, greedy legislatures and tax gatherers, declining natural resources and wars fought for them whilst in the terms of the Rvd Bayes had a small probability, but they do occur and the consequences as everyone with a pension has discovered can be brutal. This does not however prevent scientists applying the totemic value to a “statistically significant” level of P <0.05 or of you wish 95% probability and warnings have repeatedly been published about the use of such tests and the implied but nonetheless improper legitimacy it gives to results. Regrettably the need for a mantra style statement is required for admission to the leading journals. This is not to cast doubts on Dr Permohamed, as the figures they supply are simple and straightforward and the statistical analysis provided, uncomplicated and rudimentary and the data requires no further analysis. Now that the medical authorities are starting to seriously attack the negative outcomes of hospital treatment and the patients collision with the primary care system and subsequent hospitalization, albeit a concern precipitated it appears, more for economic than medical and healthcare interests. It is encouraging to see that we are getting a more detailed, precise and honest interpretation of the limits of our medical knowledge and current state of routine medical care. It is sobering to think how little effective quality control has been practised in an industry that absorbs so much of our workforce and Gross Domestic Product and the absence of regimes for effective monitoring, reporting and control, which have been standard in manufacturing industry for decades. That these are now just being considered and occasionally introduced presents a good case for seconding industrial managers on short term contracts from industry to speed up implementing such systems as a matter of extreme urgency. It is not surprising therefore that the NHS, which is such an ill managed body, which has increased expenditure in the last 5 years by 43% has so little to show in improved outcomes. Regrettably the mainstream media is more concerned with promoting the traumas and tragedies that occur than tackling the complicated issues in identifying and ultimately resolving these problems, the result of decades of obfuscation, inertia and deceit. It is the job of the profession to educate the media, and the public, however reluctant they may be to be diverted from their primary task of healthcare to explain. A Dr Hawking on Radio 5 Live discussion on Sunday 11th July was exceptional, in carefully explaining the complexities of MRSA, and that it was not simply hygiene, hand washing and historical comparisons of dirty wards, but a matter of priorities and determined detailed action, over long periods of time and that another “quick fix” was not possible nor was it the answer. This refreshing view ended a week when a small firm making air conditioning saw a 30% leap in their shares on the London Stock Market after announcing a unit that would “zap” MRSA “bugs” with Ultra Violet light and thus “solve” the problem. Elsewhere, on the BBC Radio 4 News, the husband of an MRSA victim, has prepared in his kitchen a silicon based microbiocidal hand cream he is touting, and receiving massive publicity for as another magic elixir which will eliminate this “killer bug”. It will be a long time before the media, and the public refuse to believe in the hi-tech “golden bullet” theories of healthcare and medical treatment. What would be nice to report is that the pharmaceutical industry, to which antibiotics represent 2% of worldwide sales has produced a new antibiotic. It is 25 years since any antibiotic has been produced and there is not, nor is there any imminent possibility that a new and unexplored chink has been found in the biochemical pathways and metabolic systems of the major pathogens. These communicable diseases, TB, cholera, typhoid, malaria are now only ravaging the third world, which are set to increase with population growth and with increasing low cost international travel, legal and illegal immigration and the exodus of refugees from wars for resources. This will undoubtedly start to impact on our health and health services in the developed West. It is evident that sexually transmitted diseases (STDs) are increasing (other than HIV/AIDS), both in incidence and severity, none, thankfully evidently resistant to the known armoury of the healthcare industry – although this must presumably be only a matter of time. It is for example now accepted that cervical cancer is always associated with infection with an STD Human Papilloma Virus (HPV), which can be transmitted even where condoms are used and between female sexual partners. It would be good to report that the NHS are in the vanguard of planning for the eventual consequences an impending tsunami of communicable Third World diseases and STDs. The bad news is, that the impetus for basic research is not to be found from the global pharma industries of Europe and America and the medical and healthcare establishments and Governments of the developed world. The thrust for action accompanied by substantial funds are coming from the personal fortunes and family trusts of Bill Gates and his wife and the founder of Dell computers. Meanwhile the pharmaceutical giants are desperately seeking a new disease, called female sexual dysfunction, so they can double the market overnight for sildenafyl citrate (Viagra / Cialis etc.,). The results so far, even with P<0.05 are disappointing. The lady really does have a headache. Lets hope she doesn't OD on the aspirin and end up as one more of the NHS ADRs and ends up boosting Dr Pirmohamed's revealing and alarming statistics. |
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