ORIGINAL ARTICLE

The ethics of evidence-based therapy
Where is the evidence in modern medicine?
M. L. Kothari, L.A. Mehta, V.M. Kothari

We swear by ‘science’, though the very word begs for a precise definition. Allopathy (read ‘modern medicine’) dominates the therapeutic scene because of its ostensible scientific approach. Its hegemony may be gleaned from the fact that the leading text, Clinical Pharmacology( 1), asserts non- allopathic systems do not merit to be even called ‘alternative’: “The term complementary seems to make a less ambitious claim than alternative medicine, and is preferred.” Having declared that it is “for all concerned with evidence- based therapy,” the book states: “Features common to complementary medicine cults are absence of scientific thinking, naive acceptance of hypotheses, uncritical acceptance of causation, e. g. reliance on anecdote, and assumption that if recovery follows treatment it is due to the treatment, and close attention to the patient’s personal feelings.” This article will show that allopathy commits the same conceptual crimes.

What is evidence?
The Webster’s Dictionary defines it as: “an outward indication; token; something that furnishes or tends to furnish proof; something legally submitted to a competent tribunal as a means of ascertaining the truth of any alleged matter of fact under investigation”.

Needless to say, the very tentativeness of the ‘truth’ embodied by any evidence leaves enough legitimate doubt about its veracity. What if the ‘competent tribunal’ is far from being so?

MM has put the problem in the wrong terms by calling a symptom the disease. It has compounded the situation by presuming that treating the symptom amounts to treating the disease. This is unethical: the doctor prides his ignorance, and the patient pays physically, mentally, spiritually, and of course, financially, as does the animal world that has beeen decimated in the name of evidence- based medicine.

Defining disease
A person with arteriosclerosis or “hypertensive cardiovascular disease” may be more at ease than a person with no diseased organs or tissues. A man with a large sebaceous cyst that fetches money for every appearance at surgery examinations does not have a disease, only a sebaceous cyst. Our inability to distinguish between asymptomatic structural or functional alterations - a breast lump, raised blood pressure, raised blood sugar level - and true disease makes us rush to “treat” every such “patient”.

In the absence of any precision, doctors resort to ‘pragmatic( 2) diagnosis’, and, ‘pragmatic treatment’ :“In cancer of the breast, however, one has to worry so often whether to call a tumour malignant or not; there is so much difference between opinions on borderline cases; and so much of the ‘probably not cancer but safer away’ type of diagnosis, that there can be no doubt that many tumours treated as if they were malignant were, in fact, not malignant at all.“( 2)

Those who argue that microscopic precision allows diagnostic precision should listen to McKinnon( 3) : “Today it is a safe generalisation that all competent cytologists and pathologists agree that, in histopathology, there is no sharp line dividing malignancy and nonmalignancy. But in practice, the division is made sharply, as it must be, in all cases presenting, and, naturally and unavoidably, with the diagnoses tending to the positive rather than the negative side. Though the pathologist may qualify his decision as one of opinion only, that qualification does not prevent the inclusion of the case as lethal cancer.”

An intrinsic disease is predisposed to by our vertebrateness, precipitated and perpetuated by the mere passage of time. Kurtzke (4) after a global survey of cerebrovascular disease concluded that CVD/stroke is as integral to aging as the onset/ cessation of menses or the need for reading glasses.

The microbial biomass outweighs the animal biomass 20 times over( 5), making mankind a parasite on the microbial host, alive at its pleasure.

The word infection is yet to be defined: “Infection arises when microbes enter the body, establish themselves, and multiply. Entry by harmless microbes that do not multiply in their new surroundings is not strictly infection; nor is the presence of harmful microbes on an intact body surface. In fact most body surfaces are permanently contaminated by bacteria.“( 6) Yet the obsession that fever signifies infection is so strong that the celebrated Nelson’s Pediatrics( 7) asserts: “Fever and infection in children are not synonymous.”

Medical advances have not lengthened the human lifespan( 8, 9) or abolished killers such as cancer. The untreated often outlive the treated.( 10) After a scholarly presentation of the management of cardiac failure, a leading text( 1) cautions : “Treatments which improve symptoms in heart failure do not improve prognosis - and vice versa.”

The word cure comes from the Latin.curatio, ‘I care’, and Sanskrit car ‘hand’ (11) . A doctor who uses the word cure to imply removal of a disease is a quack. Doctors cure birth by assisting it, cure life by promoting it, and cure death by easing it. In any case, none of the intrinsic diseases lead themselves to the dream of a removal.

Erik Erikson( 12) exhorted doctors to treat patients exactly as they would be treated for their own illnesses. Alas, sick doctors do not welcome the therapies they offer their patients.( 13,14,15) The doctors know that the therapies foisted on patients are avoidable.

A study( 16) to see if doctors faced with the prospect of cancer ‘practiced what they preached’ revealed that doctors do not bother to seek an early diagnosis; permit ‘unjustifiable delay’ before ‘curative treatment’ is started, and choose as initial consultant a physician whose culpability for delay is as great as that of a general practitioner. Doctors investigate and treat themselves or their relatives inadequately by conventional medical establishment standards. The BMJ( 14) asked a director of surgery what he would do if he had cancer of the rectum. His reply: “I am absolutely certain and this I am sure will bring the wrath of most colorectal surgeons on my head, but no matter - I would not have an abdominoperineal resection with a colostomy. However managed, however much we delude ourselves, a permanent potentially incontinent abdominal anus is an affront difficult to bear, so that I marvel that we and our patients have put up with it so long. It says much for the social indifference of the one and the social fortitude of the other.“( 15)

It’s a chastening thought( 17) that diseases ranging from the common cold to cancer are beyond our understanding and hurt.

“One of the early hopes of investigators in comparative oncology was that through animal research the causes of human neoplasms would be found. There continues to be such hope, but it is sobering that not one of the several recognised causes of cancer in man was found through animal observations or experiments. Many chemical, physical, viral, and parasitic agents are known to induce neoplasms in animals, but those that have been found active also in man were known to be so before the animal experiments were done.” (18) If MM has not become wiser as to the cause of cancer its record on the cure front is not better.

“Doctors are men who prescribe medicine of which they know little to cure diseases of which they know less in human beings of which they know nothing.” (Voltaire). A good 220 years later, with a Niagara of animal bloodshed, MM is groping in the dark. It is a pity that medical ethics deals with the ethics towards the animal fraternity only in passing.

Evidence of therapy
‘The art of therapeutics’, Bodley Scott said, ‘is based upon the touchingly naive assumption that there is an answer to every question it poses. ’ We always say ‘What is the treatment of this disease? ’ rather than ‘Is there any treatment for this disease? ’ It is apparently better to believe in therapeutic nonsense than openly to admit therapeutic bankcruptcy. Richard Asher( 19)

- The authors’ recent experience vis-a- vis breast cancer in two women in their early 70’s merits mention here. Mrs. Kothari, 73 and related to one of us, was found to have a sizeable breast cancer a year ago, and, was told to leave it alone. She is hale and hearty as of now. Mrs. Zaveri, much richer than Mrs. Kothari, developed a similar problem and her son consulted us. We advised that she be left alone and be allowed to go on the pilgrimage she was keen on. But scientific medicine prevailed. She was given a course of cancer chemotherapy. On the fourth day, she developed gastroenteritis with vomiting and diarrhoea. One particularly large vomit went into the respiratory tract and that was the end of a woman who came chatting and walking to the hospital.

- An editorial in The New England Journal of Medicine( 20) entitled ‘The toss- up’ states: “It is common experience that, on a given case, the proposed diagnostic or therapeutic thrust ranges from extreme conservation to surgical ultra-radicalism.” After attributing such divergence in medical thinking to the idiosyncracies of physicians, the authors propose : “Perhaps all these factors are involved in clinical controversies, but we propose that one explanation has not been sufficiently recognised: that it simply makes no difference which choice is made. We suggest that some dramatic controversies represent ‘toss- ups’ clinical situations in which the consequences of divergent choices are, on the average, virtually identical. The identicality of the consequences, no matter what the investigations and what the therapy, is a result of the basic fact that the problem being tackled is beyond the limits of technology.”

- MM can’t treat the disease, but palliates by curbing the evidence, suppressing the symptoms and excising the signs. This satisfies the physician, provides the patient with a placebo, and leaves the disease alone.

Indian scriptures have classified the problems that the human frame is prone to, into two broad groups : Gera or ageing is built into one’s development programme, being innate, inevitable, and a mere function of the temporal flow. Vyadhi or disease when independent of gera is something one invites, a situation wrought upon oneself as a result of intemperance; vyadhi is not. Many a person carries on through a long life without any disease or vyadhi.

The doctor is not capable of affecting the working of gera; but may be able to mitigate vyadhi. The failure of medicine to understand the cause, course, or ‘cure’ of age- related processes provides scientific vindication of the scriptual insights.

- Chemo-, hormono-, radio- and surgical therapies for cancer or coronary artery disease tackle manifest symptoms and signs without touching the disease itself. Glucostasis by “antidiabetic” drugs tackles only one aspect of a complex metabolic and vascular problem. Even the 1997 edition of Clinical Pharmacology (1) has given no room to the treatment of stroke, maybe from the honest realisation no treatment worth its name.

Andrew Malleson’s book, Need Your Doctor Be So Useless?( 21) broadens one’s medical perspective and enables one to give his best to the patient. A passage from the encyclopedic Oxford Companion to Medicine( 22) spells out why an epistemiologic perspective is indispensable : “Doctors, even with their superior knowledge of medicine, often behave in exactly the same way : this may seem strange but doctors have a healthy scepticism about the efficacy of the art they practice. They see patients recover from their illnesses without, or in spite of, medical help. They learn, too, to respect the healing force of nature - vis medieatrix naturae. Doctors, above all, know that from most illnesses there is spontaneous recovery. Only comparatively rarely is medical or surgical intervention needed to save life, which is the dramatic part of medicine : much more often an illness makes the patient uncomfortable and he wishes to have relief in the shortest possible time and with the least inconvenience. Moreover, the ordinary patient may have no inkling of whether his present disorder is life- threatening, or relatively trivial and likely to pass without medical help. It needs to be more generally recognised that most of medicine is about relief of, and comfort in, suffering, and in the main very little to do with saving life.”

Ethics for all
Epistemology is the science of assessing the scope and limitations of any piece of knowledge or technique. A doctor ignorant of the nature of human maladies and overconfident of MM is unethical by ignorance and arrogance. Ignorance of law is no excuse. It behoves the practitioner to communicate the uncheckable cause and course of most illnesses and the severe limitations inherent in most therapies.

A patient who expects the doctor to be ethical must be equally ethical in pruning the expectations of therapy and respect a physician with the courage to deny treatment.

An unethical society cannot beget ethical doctors. A litigant society, powered by lawyers, promotes defensive medicine to the detriment of the patient. MM is counterproductive,costly and counterproductive.

Ethicality is, in the final analysis, a complex relationship between the physician and the problem he tackles, the physician and the patient, and finally between the physician, patient, and society on one side and Nature, the animal world, and ecology on the other. A physician should not, out of ignorance, ill- treat a disease which then ill- treats the patient, and which is then called iatrogeny. The progress achieved by MM rests on a disturbed ecology and heartless animal slaughter. And that is not ethics.

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M. L. Kothari, L.A. Mehta, V.M. Kothari, Seth G.S.Medical and KEM Hospital, Mumbai 400012