“Oh! let us never, never doubt

What nobody is sure about!”
Hilaire Belloc 1870-1953



Medical information gets updated at a rate of 7% per month. Most of this is not worth knowing and some of it is downright useless, but the conscientious practising doctor would find it difficult to practise medicine without feeling guilty. The claims of heroic surgical feats and the role of wonder drugs being touted every day compound this dilemma. Most of these are not properly audited. How does one get some guidance in this jungle of confusion? That is the million-dollar question.1



Ever since medicine was accepted as a science in the European Universities in the twelfth century, medicine has 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 only follows non-linear mathematics in time evolution.2 Although natural sciences have learnt a lot from modern quantum physics, medicine did not follow suit, to understand human consciousness that critically guides human health and illnesses.3 All these factors have compounded the mistakes in applying technology to medicine without proper 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 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 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 Following those 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 opinions, unfortunately, ignored some of the very valid data in the field.7



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 There was hardly any substantial change in this area even as recently as 1997. 9 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.10 More recently an audit showed ethically unacceptable results of overuse of both bypass and angioplasty in the immediate post myocardial infarction scenario.11



Writing a very balanced editorial in the same issue, Harlan Krumholz from Yale University 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." 12



This menace is spreading to other countries, more so to the developing countries in a big way where auditing is non-existent. Earlier there was a plea for cutting cardiac surgical centres in the UK by a thinking cardiac surgeon.13 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; 14 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.15 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! 16 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 the operation is done only in rare cases for relief of intractable angina and/or for stabilizing ventricular function.17 Poor medical research might be due to the vested interests enticing researchers with gifts and other allurements.18,19



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.20. Renal angioplasty is no better than anti-hypertensive therapy, although sold as the best for the former.21





Another area that has not been audited is the routine check up (screening) 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 of diseases could control them better and also prevent further damage. 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 multi-factorial, long-term preventive strategies to prevent cardiovascular diseases showed that at the end of fifteen years of observation there were significantly excess cardiac deaths in the intervened group as compared to the controls.22 Screening for congenital hypothyroidism, breast cancer, and Down's syndrome had 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. In addition people who get negative results on screening are shown to ignore health precautions. In Australia this has resulted in higher episodes of illness. More studies are needed before launching whole sale screening programmes. 23



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, since medical students are taught to be totally dependent on technology for diagnosis. A recent audit of the diagnostic methods did show that 80% of the final accurate diagnosis and one hundred percent of the future management strategies, could be deduced at the end of reading the referral letter and listening to the patient. It could only be improved 4% by all the examinations and 8% more after all the tests, including positron emission tomography, are done.24



Medical education seems to be run mainly with the money from drug companies and technology manufacturers.25 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.26



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.27 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.28 None of these findings either reach the practising doctor or even the text books, but the twisted version reaches, through the glossy company literature, every practitioner long before the study gets published!



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.29 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.





Future Course:



Value based medical education, preferably in the community, would solve some of the problems, like over-investigation and over-treatment that result in many Ulysses syndromes. Rather, teaching in the hi-tech set up should be discouraged to make the doctor-patient relationship the sheet anchor of medical care delivery. Medical students should have lessons in medical humanism, which includes insight into the real health problems and their solutions. Research must be better regulated. Financial interests of the researchers need to be carefully assessed before publishing their data. Time is now ripe for openness in research.



The profession, before being advertised to the gullible public, should evaluate newer heroic surgical feats that bring in fame, money and status to doctors, hospitals and the manufacturers of equipment. Deportation of the physician under the most draconian law in South Africa, in the much publicized first heart transplant, for refusing to declare the donor brain dead, is a glaring example of what happens behind the scenes in such situations. We need stricter control over these heroic procedures where the real hero is the patient who offers himself for the procedure unaware of its implications and hazards. Interventions could be audited, like drugs, by controlled studies. Many new techniques had resulted in mortality and morbidity in the past: they are too many to enumerate! Most of them have been swept under the carpet.



Medicine revolves round anxiety-patient anxiety of disability and death and doctor anxiety of having done enough of the right thing or not. If something could be done to allay both these, we will have progressed in the right direction. Doctor’s dilemma that causes so much of stress related diseases among doctors goes unnoticed to the detriment of patients and the public. This has to be urgently addressed by the profession as also the powers-that-be. This is not a small matter. Hope sanity will prevail and medical education gets suitably modified with special stress on continued rounded professional development.



"Of the terrible doubt of appearances,

Of the uncertainty after all-that we may be deluded…."

Walt Whitman.



Acknowledgement:

I am grateful to Prof. Hussein Dasti, the editor of Kuwait Medical Journal, for permitting me to draw liberally from my editorial in his journal.1



BIBLIOGRAPHY





01. Hegde BM. To do or not to do-doctors’ dilemma. Kuwait. Med.J 2001; 33: 107-110.

02. Firth WJ. Chaos-Predicting the unpredictable. BMJ 1991; 303: 1565-1568

03. Schmahl FW and van Weizsacker CF. Medicine and Modern Physics. Lancet 1998; 351: 1291-92

04. Spodick DH. The Swan-Ganz catheter. Chest 1999;115:857-858

05. 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

06. Robin ED. Death by Pulmonary Artery Flow Directed catheter. Chest 1987; 92: 727-731

07. Weil MH. The assault on the Swan-Ganz catheter. Chest 1998; 113:1379-86

08. Spodick DH. Revascularization of the heart-numerators in search of denominators. Am Heart J 1971; 81: 149-157

09. Hegde BM. Coronary Artery Revascularization-Time for reappraisal. Proc. Roy. Coll. Physi. Edinb. 1997;

10. Graboys et. al Second opinion trial JAMA 1991; 266:1523-1528.

11. 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.

12. Krumholz HR. Cardiac Procedures, Outcomes, and Accountability. N Engl J Med 1997; 366: 1522-23.

13. Treasure T. Coronary Investigations. Lancet 1993; 341: 154

14. Yusuf S, Zucker D, Peduzzi P et al. Effect of CABG on 10 year survival. Lancet 1994; 344: 563-570

15. Hux JE, Naylor CD. In the eye of the beholder. Arch Intern Med 1995; 155: 2277-2280

16. Marcia Angell. Is Academic Medicine for Sale? N Engl J Med 2000; 342: 1516-1518

17. Selens OA and McKhanna GM. Coronary artery Bypass surgery and the Brain. N Engl J Med 2001; 344: 451-453

18. Altman DG. The Scandal of Poor Medical Research BMJ 1994; 308: 283-4

19. Campbell EG, Louis KS, Blumenthal D. Looking the Gift Horse in the Mouth. JAMA 1998; 279: 995-999

20. Kalaycioglu S, Sinci V, Oktar L. CABG after successful PTCA: is PTCA a risk for CABG? Int. Surg 1998; 83(3): 190-193

21. Ritz E and Mann JFE Renal Angioplasty for Lowering Blood Pressure. N Engl J Med 2000; 342: 1042-1044

22. 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

23. Stewart-Brown S and Farmer A. Screening Could seriously damage Your Health. BMJ 1997; 314: 533

24. 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.

25. Editorial. Drug-Company influence on medical education in USA. Lancet 2000; 356: 781

26. 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

27. 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

28. Anderson OK, Almgren T, Persson B et al, Survival of treted hypertension: Follow up study after two decades. BMJ 1998; 317: 167-171

29. Charatan F. Medical errors kill almost 100,000 Americans a year BMJ 1999; 319: 1519