TO DO OR NOT TO DO- DOCTORS' DILEMMA.
Posted by bmhegde on 1
"Knowledge" said Karl Popper " advances NOT by repeating known facts, but by refuting false dogmas". One can not agree more. Modern medicine abounds in dogmas: many of them have not been scientifically audited. Science is change. Every single hypothesis is true until refuted by new knowledge. Knowledge today in the medical field is replaced by information, resulting in doctors relying only on information and not wisdom. The so-called evidence based medicine really is evidence burdened.
Wisdom alone should, therefore, guide the profession in CARING for our patients. Wisdom comes out of empirical experience based on information and knowledge. However, medical muddling seems to be a profitable business. New tests, new devices, and even new drugs pour into this arena on an unprecedented scale.
It is time to audit all the technologies used in patient care just as we have placebo-controlled trials for drugs before releasing them for human use. Even in the case of drugs, in some rare instances, release of drugs for patient use before being audited by such trials had resulted in major damage resulting in their withdrawal from the market.1 It stands to reason that we should debate the issue of auditing untested technologies that get into the arena of patient care.
Ever since medicine was accepted as a science in the European Universities in the twelfth century, we have been using the methods of natural sciences including the use of linear mathematics. This has resulted in "doctors predicting the unpredictable" as the dynamic human body follows non-linear mathematics in time evolution.2 (Firth WJ. Chaos-Predicting the unpredictable. BMJ 1991; 303: 1565-1568) Although natural sciences have learnt a lot from modern quantum physics, medicine did not follow those advances, to understand human consciousness that critically guides human health and illnesses.3 (Schmahl FW and van Weizsacker CF. Medicine and Modern Physics. Lancet 1998; 351: 1291-92) All these factors have compounded the mistakes in applying technology to medicine without any audit.
Starting with some of the audits just completed, we could move on to other areas. Many of the unmeasured physiologic effects of indwelling catheters come to mind first. The Swan-Ganz catheter was introduced without appropriate validating studies to compare with identical groups without the catheter. This catheter by itself could be an adverse factor for many critically ill patients.4 (Spodick DH The Swan-Ganz catheter. Chest 1999;115:857-858) In an observational study Connors and colleagues showed that in critically ill patients, after adjusting for selection bias, the catheter was associated with increased mortality and increased utilization of resources.5 (Conners AF, Speroff T, Dawson NV, et. al The Effectiveness of Right Heart Catheterization in the Initial Care of Critically ill Patients. JAMA 1996; 276: 889-897) The authors suggested a prospective randomized study. Extrapolating another study done in Worcester, Robin estimated that around 15,000 unnecessary deaths could have occurred in the year 1984 alone and his paper goes on to estimate a total of nearly 100,000 excess deaths in the USA since1975 due to the catheter.6 (Robin ED. Death by Pulmonary Artery Flow Directed catheter. Chest 1987; 92: 727-731). Following these studies there was a justifiable demand for a moratorium on the use of the catheter until further prospective controlled studies clear the mist. Understandably, there were strong opinions expressed against the demand for a moratorium, but the opinion, unfortunately, ignored some of the very valid data in the field.7 (Weil MH. The assault on the Swan-Ganz catheter. Chest 1998; 113:1379-86)
Coronary artery surgery is the next popular surgical procedure crying for proper audit. There was a demand for audit in this area way back in the early 1970s, indeed all new surgical procedures be better audited by controlled studies before being routinely performed in practice.8 (Spodick DH. Revascularization of the heart-numerators in search of denominators. Am Heart J 1971; 81: 149-157) There was hardly any substantial change in this area even as recently as 1997.9 (Hegde BM. Coronary Artery Revascularization-Time for reappraisal. Proc. Roy. Coll. Physi. Edinb. 1997;) A well planned prospective second opinion study of the need for bypass grafting showed that there is a major overuse of this procedure even in the best centres in the US.9 (Graboys et. al Second opinion trial JAMA 1991; 266:1523). More recently an audit showed ethically unacceptable results of overuse of both bypass and angioplasty in the immediate post myocardial infarction scenario.10 (Tu JV, Pashos CL, Nayler CD et al. Use of cardiac procedures and outcomes in elderly patients in the US and Canada. N Engl J Med 1997; 336: 1500-5.)
Writing a very balanced editorial in the same issue Harlan Krumholz from Yale laments: "In a fee-for-service system, cardiac procedures generated billions of dollars in revenues each year. A high volume of procedures brought prestige and financial rewards to hospitals, physicians, and the vendors of medical equipment. In this environment, the US health care system rapidly produced and expanded the capacity to perform cardiac procedures and training….This increased capacity may also have fuelled demand for procedures." 11 (Krumholz HR. Cardiac Procedures, Outcomes, and Accountability. N Engl J Med 1997; 366: 1522-23.) This menace is spreading to other countries, more so to the developing countries in a big way where the auditing is non-existent. Earlier there was a plea for cutting cardiac surgical centres in the UK by a thinking cardiac surgeon.12 (Treasure T. Coronary Investigations. Lancet 1993; 341: 154) Journal editors could do a lot to avoid cognitive errors in data presentation as shown by this review of 60,000 bypass grafts in the US. While the original study said that everyone that undergoes an early bypass graft has an average increase in life expectancy of 4.26 extra months; 13 (Yusuf S, Zucker D, Peduzzi P et al. Effect of CABG on 10 year survival. Lancet 1994; 344: 563-570) the truth of the matter when properly presented was that 6% of patients gained extra life of 3.5 years from early surgery, 4% gained 1.5 years and the bulk of 84% had no change at all.14 (Hux JE, Naylor CD. In the eye of the beholder. Arch Intern Med 1995; 155: 2277-2280) This brings us to the crucial question if this kind of publications are done and researchers hired only to sell academic medicine in the market! 15 (Marcia Angell. Is Academic Medicine for Sale? N Engl J Med 2000; 342: 1516-1518) To cap it bypass surgery of the coronary arteries is associated with adverse effects on the brain. Stroke, that occurs from 1.5 to 5.2 per cent of patients undergoing this procedure according to various prospective studies, post-operative delirium, short term cognitive changes and in many cases long term permanent cognitive changes make it imperative that operation is done only in rare cases for relief of intractable angina and for stabilizing ventricular function.16 (Selens OA and McKhanna GM. Coronary artery Bypass surgery and the Brain. N Engl J Med 2001; 344: 451-453) Poor medical research might be due to the vested interests enticing researchers with gifts and other allurements.17,18 (Altman DG. The Scandal of Poor Medical Research BMJ 1994; 308: 283-4) (Campbell EG, Louis KS, Blumenthal D. Looking the Gift Horse in the Mouth. JAMA 1998; 279: 995-999)
There is nothing much to write home about the outcomes of another related procedure, angioplasty. Whereas there are small studies eulogizing its benefits, there are enough audit data that do not show the procedure in very good light.19 (Kalaycioglu S, Sinci V, Oktar L. CABG after successful PTCA: is PTCA a risk for CABG? Int. Surg 1998; 83(3): 190-193. Renal angioplasty is no better than anti-hypertensive therapy, although sold as the best for the former.20 (Ritz E and Mann JFE Renal Angioplasty for Lowering Blood Pressure. N Engl J Med 2000; 342: 1042-1044)
Another area that ha snot been audited is the routine check up of apparently healthy individuals. While it is true that doctors and technology could do a lot for the hapless victims of illnesses, there is no solid proof that our interference at the so-called "early asymptomatic " stage diseases could be better controlled and prevented. Human body's wisdom tries to do the necessary changes when things go wrong anywhere in the body. Only when this body's defense fails does a patient get symptoms. That is where our intervention would help. An audit of multifactorial long-term preventive strategies to prevent cardiovascular diseases showed that at the end of fifteen years of observation there were significantly excess cardiac mortality in the intervened group as compared to the controls.21 (Strandberg TE, Salomaa VV, Naukkarinen VA. Et. al. Long- Term Mortality After 5-Year Multifactorial Primary Prevention of cardiovascular diseases in Middle aged Men. JAMA 199; 266: 1225-1229)
Screening for congenital hypothyroidism, breast cancer, and Down's syndrome have shown false positives to have permanently damaged the health of the screenees. Sick absenteeism increased significantly after the work place hypertension screening was started. Similar results came from some of the cholesterol check up programmes. People who get negative results on screening are shown to ignore health precautions. In Australia this has resulted in higher episodes of illness. More needs to be studied before launching whole sale screening programmes. 22 ( Stewart-Brown S and Farmer A. Screening Could seriously damage Your Health. BMJ 1997; 314: 533) However, this practice is spreading like wild fire all over the world since it makes lot of business sense to tell the world that we could do a lot to all the well people, as we would then be targeting a huge population with this false claim!
The menace of technology is taking a heavy toll on the health budgets of poorer countries as medical students are taught to be totally dependent on technology for diagnosis, while an audit of the diagnostic methods did show that 80% of the final accurate diagnosis could be arrived at the end of reading the referral letter and listening to the patient; while it could only be improved 4% by all the examinations and 8% more after all the tests including positron emission tomography are done.23 (Hampton JR, Harrison MJG, Mitchell JRA. Et. al Relative Contributions of History Taking, Physical Examination, and Laboratory Investigations to Diagnosis and Management of Medical OutPatients. BMJ 1975; 2: 486-489.) Medical education seems to be run mainly with the money from drug companies and technology manufacturers.24 (editorial. Drug-Company influence on medical education in USA. Lancet 2000; 356: 781)
Research data are many times twisted out of shape to help sell drugs and technology making life miserable for patients and possibly also increasing mortality. Most studies are subject to interpretation bias as shown elegantly by the now infamous UKPDS data. This study does not show any benefit on macro-vascular end points in patients with type 2 diabetes treated with insulin and sulphanylureas, nevertheless many authors, editors and the wider doctors' community interpreted this very study as providing evidence of benefit of intensive blood glucose control.25 (McCormack J and Greenhalgh T. Seeing What You Want To See in Randomized Controlled Studies: versions and perversions of the UKPDS Data BMJ 2000; 320: 1720-1723) The story of HOT study for tighter control of blood pressure is another pathetic story in this regard. While the study was stopped prematurely as there were higher deaths in the tightly controlled group with more powerful modern drugs, the study results were sold as showing benefit to patients with these drugs. Although many patients dropped out of the study in the beginning the study was eventually analyzed by using the intention-to-treat analysis. Fundamental objectives of the HOT study remain to be achieved. 26(Hansson L, Zanchetti A, Caruruthers SG, et.al, HOT Study Group. Effects of intensive blood pressure lowering and low dose aspirin in patients with hypertension. Lancet 1998; 351: 1755-62) Treated hypertensives had impaired mortality compared to their normotensive cousins, which becomes apparent after a decade of follow up showing that all is not well with antihypertensive treatment the way it is done these days.27 (Anderson OK, Almgren T, Persson B et al, Survival of treted hypertension: Follow up study after two decades. BMJ 1998; 317: 167-171) None of these findings either reach the practising doctor or even the text books, but the twisted version reaches even before the study gets printed!
All this has created enough and more damage to the medical profession. There needs to be a fundamental change in medical education to make the new doctors to think for themselves before accepting published data unquestioningly. We should provide students with all the facilities to learn for themselves rather than trying to teach them. Shocking revelation that in USA around 100,000 people die every year due to medical errors makes one to think if we are on the right track or not. The numbers could be much higher in some of the developing countries.28 (Charatan F. Medical errors kill almost 100,000 Americans a year BMJ 1999; 319: 1519) Medical education should not exist to provide doctors with an opportunity to earn a living, but it should exist only to improve the health of the public.
Time evolution in a dynamic system like the human body depends on the total initial knowledge of the organism. To know the future of man one should have an idea of his consciousness in addition to the phenotypic features that we have been depending on all along to predict the future. Consequently, "doctors have been predicting the unpredictable". With quantum physics trying to explain the human consciousness we would be able to study the human mind better in the near future. Mind is not only in the brain but is only a quantum concept residing in every human cell at the sub-atomic level.29(Stuart AE. On Being Conscious Proc. Roy. Coll. Physicians Edinb. 1997; 27: 68-77) But we have been barking up the wrong tree all along in search of quick fix methods for man's problems.30, 31 (Hegde BM. Are we barking up the wrong tree? The Cardiologist (India) 2000; 3: 1-3) Hegde BM. Need for change in medical paradigm Proc. Roy. Coll. Physicians Edinb. 1993; 23: 9-12)
A pill for every ill is not true. Medicine would always try to "cure rarely, comfort mostly, but console always." The human and humane doctor is a very vital tool in stimulating the body's immune system in every disease situation for healing. Primum non nocere (first do no harm) is an old but true dictum to follow. Let us not make our intervention worse than the patient's suffering. The time for openness has come and openness would be more relevant in the new millennium. There are a lot of things that we should not be doing in medicine. We better act quickly to demolish those myths before more damage is done and the credibility of the medical profession is tarnished. The fine art of medicine, that is affecting the quality of the patient's day, that is the highest of arts. Medicine is an art based on sound scientific principles. Ever since medicine was accepted as a science in the European Universities in the early twelfth century medicine relied on natural sciences and linear mathematics. That is where the problem is. Human body follows non-linear mathematics! Physician, heal thyself first.
" Fear not! Life still
Leaves human effort scope.
But, since life teems with ill,
Nurse no extravagant hope.
Mathew Arnold. Empedocles on Etna.