When the phrase was first coined, “evidence-based medicine” (EBM) simply referred to the use of therapy that had been proved and tested in a rigorous manner to the point of its becoming “state of the art.”[1] EBM has not escaped criticism either because of the assumptions it makes or for the way it has come to be used. Indeed, some of its critics have gone so far as to call reason “the most stiff-necked adversary of EBM.”[2] If one strictly adheres to the terminology and resultant definition (ie, that “good” medical practice must be based on evidence that “x” is helpful in treating disease “y” for a particularly defined group “B”) one can hardly oppose EBM outright. Presumably the only alternative to that definition would be “myth or rumor-based medicine” (quote attributed to Dr. Thomas Frühwald, a friend and colleague from Austria) which is, obviously, not acceptable when true and valid EBM is available and seems appropriate. Nevertheless, as it now stands, if EBM is applicable anywhere, it is applicable at the bedside and certainly not in experimental procedures, the very essence of which is to go beyond what we already know.

I shall use “evidence” here to mean a statistically valid conclusion about a rigorously defined cohort. It is evident that properly trained biomedical statisticians must deal with statistics and that what constitutes a properly defined cohort (say, healthy Chinese males aged 20–30 years) is determined by physicians and ethnologists who are experts in what is being studied and in etymologic data.

Because we communicate in words, utmost rigor is necessary. Much, however, that is touted as “evidence” is evidence for only a particular cohort under particular circumstances and may be entirely inapplicable in another. What is “evidence” for a 22-year-old male is not automatically applicable to a 66-year-old female. What is “evidence” for 22 year-old Chinese males may not be applicable for 22-year-old black females – simple logic should tell one these things.

We must, I think, be most careful in defining what we will accept as “evidence.” Further, there are always “sports,” ie, people who, while they fit as nearly as one can tell into a particular group, nevertheless respond differently from their cohorts. EBM speaks about a large statistical group of people and, therefore, cannot simply be mindlessly applied to the individual patient. Unfortunately, EBM is often used inappropriately. In truth, the actual hard evidence (double-blind studies applied to a specific group) is often badly lacking. And because good ethics begins with good facts, the quality of the facts themselves takes on ethical significance.

Patients differ in age, sturdiness, antecedent or concomitant disease, and a host of other pathophysiologic facts. Just as important, they differ in cultural, social, and economic factors. When confronted with an individual patient it is often hard to determine just who fits where. Surely a 25-year-old well-fed Asian college student who does not drink alcohol and who develops pneumonia is not legitimately placed in the same group as a 20-year-old white unemployed person who drinks heavily and whose nutritional intake is inadequate. EBM perforce is based on averages with the inescapable Mrs. Smith who may not fall into the Gaussian curve.

We must, first of all, understand how the concept “normal” is determined. Let us say we desire to set a range of “normal” for BUN. A certain number of allegedly (deemed by statisticians to be adequate for the study) healthy volunteers have their blood taken and inevitably will have a range of BUN going from low to high. The curve will always be the same bell-shaped curve. To be on the conservative side, the lower as well as the higher values are excluded and the rest of what remains is called “normal.” This does not mean that the 5% on either side are “diseased”; once again, it simply indicates that while you can use a large number of allegedly well persons to determine a range of “normals,” you cannot reverse the process and apply it to the patient being examined. For example, a patient with a BUN of 22 cannot immediately be assumed to have renal disease.

Statistical data are just that: They tell us, for example, whether a given group of people (and here what is meant by “group” is essential to know) do better with drug “A” or with drug “B,” but they tell us little about any individual patient actually being treated.

One of the other problems is that EBM began as a helpful memory jogger – a reminder of what, in general and for the most part, was superior to other ways of proceeding. Unfortunately, EBM has tended to become a straightjacket, and physicians who deviate from such EBM algorithms risk being “called on the carpet.” Some EBM was motivated by the desire to provide the best and most modern care available; however, like “quality control,” it has had increasingly less to do with the patient's good than with institutional costs and profits. There is nothing wrong with cost control as long as it is labeled as such instead of being used as a euphemism for quality or evidence. But when we as humans allow disingenuousness to become the norm, and are no longer disturbed by lying for the sake of convenience or using euphemisms with a wink and a nod, hypocrisy becomes the norm and society as well as the profession frays. It almost seems that this is the age of euphemisms. In a society that prides itself on a superficiality of “political correctness,” this should come as no surprise.

Further, we specifically have to be careful with what we call “evidence-based medicine.” Evidence gathered in 20- to 30-year-old athletes cannot be transposed to 50- to 60-year-old women who lead sedentary lives. One cannot extrapolate from adult to infant or from a middle-class American family to Australian Bushmen. Except for the fact that this misapplication inexplicably continues to happen daily, it would not seem to be worth mentioning. How do we define “evidence”? By whose criteria? What constitutes acceptable evidence? Furthermore, individuals often handle drugs differently; one person may metabolize drugs rapidly and therefore need a higher dose or more frequent administration even though EBM would indicate that most people would not. Most elderly people metabolize drugs more slowly, but some do not. When a patient tells his/her physician that s/he has always degraded or excreted drugs rapidly, the answer “Well, you shouldn't; you are over 70” strikes one as absurd – except that I have actually heard it, or something similar, expressed on several occasions. It is one of the classic ways in which statistics are misused.

Unfortunately, just because something new has been discovered, tested, and found to “work well” does not mean that it is correct. I remember (this will reveal my vintage) when an antimicrobial called “oleandomycin” was discovered and was glowingly reviewed in the literature. A few years later it was found to be worthless in infection and is now rarely used in place of erythromycin in gastric motility disorders. Imagine if EBM would have, at the time when enthusiasm for oleandomycin ran high, included it in their recommendations. There will be “heretics” who simply are skeptical that what we consider to be true is true – often their ideas go unpublished, are scorned, and sometimes years later are considered to be “revealed wisdom.” The story of Helicobacter pylori as causative in a large percentage of peptic ulcer disease should serve as a warning; it did not then fit in with the prevalent “dogma” of medicine and, therefore, could not even be published. Refusing to publish a paper, by the way, may be a highly effective form of censorship. We badly need a “Journal of Negative Results” devoted to experiments that proved a reasonable hypothesis to be untrue. What we painstakingly find not to be true is at least as important as what is thought to be true and may prevent a repetitive trip down a cul-de-sac.

The problem, as usual, is money. Most institutions in which research is done, and most pharmaceutical companies giving grants, have a clause permitting the researcher to publish negative results. In theory, there is no reason why findings that do or do not substantiate the value of the drug being tested should not be labeled as “inferior” or as having significant side effects. After all, the research presumably passed Institutional Review Board (IRB) standards. Another favorite trick is to compare the new drug “X” against the “old drug” or “against a placebo.” The reason pharmaceutical companies like placebo trials is that outcomes are far more impressive when the new drug “X” is being tested against a placebo rather than against an established – albeit only modestly satisfactory – drug.

However, where there is a will, there is a way. The experimenter is entirely free to publish results that show that the drug being tested is inferior to the currently used drug. The next time the experimenter applies to the company for a new grant, does anyone truly think that the experimenter's honesty and forthrightness will not affect the outcome? Obviously the experimenter is entirely free to publish results that show that the drug being tested is inferior to the standard of treatment. However, journals, which rely heavily on advertising from such companies, may be loathe to risk publishing papers that are unfavorable to their advertisers.

I fully agree that much of what we do in medicine lacks rigorous justification and is based on anecdote. Why do we counsel antibiotic prophylaxis before patients with valvular heart disease have teeth pulled (but not before colonoscopy or tooth cleaning)? Does the Swan-Ganz catheter truly provide us with useful information? There are hundreds of these prejudices or myths in medicine that have become so entrenched that no IRB would permit establishing a control group to measure otherwise and we, therefore, probably shall never know. If, however, we go down the road of EBM we must rigorously define and rigorously apply the criteria we establish, and must be ever aware of the dangers and not merely embrace the advantages. Physicians must have sufficient elbowroom to deviate for good reason from the current EBM.

EBM has to be seen through the filter of personal training and experience precisely because EBM does not and cannot control for all variables, and personal experience provides those variables. It is like the difference between experimental equipoise and personal equipoise. The former refers to statistics, the latter to statistics seen through the eyes of personal experience.[3]

Furthermore, and to me of extreme importance, EBM protocols must, like drugs or food, have an expiration date after which they have to be reexamined in far more than a perfunctory way to make sure they are still legitimate. Reevaluating EBM protocols would, furthermore, be a wonderful opportunity for one part of CME.

Most things we do in medicine today are by no means strictly evidence-based; one hopes that this will change but only after the term “evidence” is strictly applied. But even then, medical treatment consists of a lot more than prescribing drugs or operating on people. Physicians themselves are by their very nature therapeutic tools – something that cannot be weighed and measured the way EBM would suggest. There is and always will be a difference between Mrs. Smith and Mrs. Claudesky who have the same pathology but are quite different people. “One size fits all” does not work well for clothing; it works not at all in medicine.

Every clinician with some experience develops a sixth sense about many of his or her patients. I have countless times been at a bedside when all the “numbers” were heading in the wrong direction, when the patient's vital signs were flickering dangerously, and when statistics would tell us that the patient's chances for recovery were virtually nil. EBM would have counseled one to stop. When a physician has known a patient for some time and many statistics would suggest “throwing in the towel,” the physician's hunch that this patient will make it must also, in my opinion, be thrown into the equation. It is a very uncomfortable feeling to go against what is considered “standard of care” and not to throw in the towel when overwhelming evidence points to a patient's imminent demise. But it is more uncomfortable not to do so than to see a patient come to irreversible harm.

Sometimes we are fooled or swamped by wishful thinking. But sometimes we are not, and despite all evidence the patient lives. We generally call this a “hunch,” but I believe that it is no less “scientific” than are the “numbers” or the x-ray. This “hunch” of ours is made up of many small things that we cannot really dissect apart: our particular experience with that disease, our having known the patient and his/her will to live and ability to fight against adversity, our knowing a patient over the years and knowing how s/he has reacted to chemical changes (within limits not all patients react the same). We have come to know how they look when confronted with some other life crisis – how they look when all is lost and how they look when they are still struggling with a chance to win. Persons are assuredly created equal; that is, they ought to have the same chances to pursue their interests and learn to use their talents. But just as assuredly, because individuals have different abilities and talents, we do not live or die equally.

These hunches (or intuitions, if you prefer) are highly individualistic and are not something mysterious or occult. For me, they are uncomfortable because they often truly transcend reason. They consist of our integrating a large number of facts very quickly and sometimes quite substantially – but they are not sent to us by heaven. Rather, they are a product of our reasoning from many facts that we know and which together form what Stewart Hampshire would call a compost heap[4] – something that can no longer be separated into its component parts but one which has formed a substance all its own. One cannot practice by hunches alone; that would obviously be insane. But one ought not to reject hunches outright and merely because they deviate from the EBM of the day.

This kind of “hunch” does not lend itself to EBM, which consists of a collection of numbers allegedly having the same implication for every member within a specific group. Not only is this inhuman, but it is also truly bad patient care and is, therefore, ethically suspect. I am not suggesting that hunches necessarily should be acted upon; what I am saying is that they must figure into the equation at least to the extent that they are positive; ie, if the “numbers” tell me that this patient is moribund and I have a hunch that this may not be so, following that hunch (even when wrong) is unlikely to harm the patient. Unfortunately, what lurks behind much of EBM and rigid protocols has more to do with material profit and loss than too many would like to admit.

The obverse is very likely to occur also. If we are to use EBM humanely and efficiently, we would be compelled, I think, to allow physicians within reason to “play their hunches.” Physicians who operate according to their hunches most of the time obviously (and with good reason) should be suspect – suspect, not guilty – of practicing poor medicine until the individual circumstances are investigated. Statistics are very helpful and sometimes critical to our understanding of a case. But we should never forget that statistics apply to groups of people and not to unique, identified lives – namely, to a particular patient in the sickbed.

Progress, be it in science, art, or philosophy, is made by questioning the status quo, by questioning the way we habitually proceed, and eventually by modifying the old or trying the new. EBM, for all its advantages in caring for the “usual case of ”X," tends to suppress our curiosity and imagination[5] or at least tends to channel our curiosity and shape our imagination within narrow limits and, therefore, gets in the way of the sort of speculation necessary for scientific progress.[6]

I would have no problem with EBM – with, in other words, having drugs and procedures rigidly evaluated before their release (with proper warnings) to the public whether by prescription or over the counter. I do fear that EBM findings soon become protocols which are suggested or are used to jog a physician's memory, and that these in turn become the norm in which the physician admitting a patient with pneumonia only writes “pneumonia protocol” often not even knowing what follows. Soon this is the standard of care, and physicians who do not follow that protocol are called on the carpet. My greatest fear, then, is not EBM but the use to which it is put. What I hear from colleagues around the country is that saving money has a lot to do with how a protocol is written. I fear these protocols mainly because they are an anti-intellectual way of practicing medicine. I shudder when I think that a physician, when asked why he did this or that, will answer, “Because that's what it says in the ‘protocol.’” I suggest that that would be too bad in an EMT or NP; but in an MD, for whom the proper priority is thinking and then writing, this is a demeaning and ultimately dangerous habit.

I suspect that the emphasis on EBM, as well as the consequent keeping curiosity and imagination within narrow bounds, is in large measure due to our society's preoccupation with profit. Except for the “not for profit” managed care organizations (MCOs) (of which there are not many), healthcare has primarily been a system in which profit (admittedly or not) is the prime interest. It is not surprising that the main interest of the CEO of any of these associations is to make a profit for the company and, indeed, the primary obligation is to the stockholders in the company. As a result, “efficiency” is of the greatest importance. Politicians, on the other hand, are elected by citizens who they are supposed to represent and whose welfare should be – but, of course, often is not – their principle concern.

In my view, “efficiency” is not a legitimate measure of the quality of healthcare or of education (which does not mean that inefficiency should be encouraged!). To have – as recently happened to me – one's physician forced to defend to a clerk (who probably at best had a high school diploma) why she considered 40 mg of a medication proper for me and why 20 mg would not do is demeaning to the physician, dangerous for the patient, and by any reasonable definition constitutes the practice of medicine without a license to do so. This struggle took quite a bit of time day after day and certainly is an insult to a splendidly trained, competent physician.

As far as research is concerned, bioethicists, as well as physicians, have rightly been eager to protect the patient, to verify that experimentation takes place only with the full consent of the patient, etc. We have tried to protect patients from overtreatment just as we have tried to protect subjects from unwarranted experiments. Unfortunately, we have done little to protect future (and sometimes current) patients from “undertreatment,” – that is, (1) giving up too soon; (2) “selling patients out” to their supposed autonomy;[7] and (3) refraining from following some highly promising leads (such as stem cell therapy and experimentation). If we are to use EBM and the protocols that invariably follow, we shall have to leave the possibility of experimental therapy open. Further, I suspect that EBM – while allegedly protecting the patient – has mainly been used (somewhat like “quality control”) as a handy foil for those interested in holding down costs. The fact that, like the Nazi government, we feel the necessity to hide what we are doing under euphemisms speaks volumes.

As mentioned earlier, it is not rare that certain racial groups or females were, by virtue of their race or sex, denied the chance to volunteer for experiments. This makes the findings specific, let us say, to white males between the ages of 20 and 30. It is inappropriate scientifically (and good ethics must start with good facts) to apply such findings in a 70-year-old black woman. Some studies will seek out legitimate ethnic groupings; we do not expect to find many white people with sickle cell anemia or many Norwegians with Tay-Sachs. On the other hand, the fact that hypertension in blacks appears to be a far more devastating disease merits studying such groups separately. But otherwise, when we study such things as infectious disease, parkinsonism, or epilepsy, there is no appropriate reason to exclude women or blacks.

Nevertheless, all such studies show is that a certain group is “more (or less) apt to respond in a certain way” but it does not speak directly to a specific patient. All it can tell us is that in general and for the most part it may be wise not to start treating a hypertensive black male with beta-blockers. But even knowing this, it is still the individual patient who is being treated. Take, for example, a 25-year-old black man with a pulse of 90, fairly anxious and not thyrotoxic: Starting to treat such a patient with a beta-blocker first – even if it happens to run counter to EBM – is not unreasonable.

But when we study the effect of drugs we should be attentive to apparent differences in such groups. In choosing initial therapy, the physician has to weigh many factors in starting therapy: heart rate, easy perspiration, and ethnic factors. These groups may respond differently to these drugs but that is precisely why such experiments should (with large enough cohorts) do such preliminary studies with a broad base and then concentrate on particular groups. It seems well established that young, black males statistically respond less well to beta-blockers than do their white counterparts. Having seen this as strongly suggestive in experiments, one might then be justified to use a group of black vs a group of white subjects who are otherwise as identical as possible in dissecting out the differences. But even having done this, it is still the individual patient who is being treated.

EBM, unless it is tried in different groups and under different circumstances, must be used with great caution. We must know precisely what the criteria for selection were and why these were chosen and not others. New drugs tried in females during their menstrual years is indeed risky, and not accepting them as subjects unless they take birth-control pills or have Norpace placed subcutaneously introduces yet another variable in the equation – and yet this separate group will have to be tried if a needed drug is to be made available. One thing we cannot do – and call it EBM – is to extrapolate, for example, from a pure male group to females or from a young group to elderly persons.

Interestingly enough, patients in double-blind studies in general want to be on the new rather than the old plan. This is a form of positivism, for it may well turn out that the new is more dangerous or less effective than the old. In giving them the information necessary to obtain informed consent or refusal, this must be made crystal-clear to the patient. Newer (or more) is not therefore better. EBM protocols, fortunately, do not (yet) control people in studies.

One of the deplorable things that have occurred in the United States is television, newspaper, and magazine advertising for certain prescription medications urging patients to ask their physician to prescribe a specific drug. Never mind that it is extremely expensive or that generics or another nongeneric does the same thing at a lower cost. The rise in drug prices has been astronomical at a time when generic forms or those made by another company are much cheaper. EBM often plays a role in hospital formularies. This is all well and good, but not if “evidence” is the drug-salesman's latest pitch. Research – a public good because health is a public good – has become a fertile tax write-off. And yet much of what drug companies call “research” is merely rearranging a molecule so that it is at least as effective as that of one's competitors, and serves as a further excuse to keep the price of medicines artificially high. The United States by far leads in the price of drugs; drugs made in the US are sold much cheaper in Canada or the European Union.[8]

EBM, then, could be a fine thing if we use it as a guide only for the proper group that was studied and if we begin to realize that it was originally meant to give priority to the good of patients, not stockholders. Constructing an EBM protocol (again, with serving the patient's good in mind) can be an excellent learning experience, whereas merely following an EBM is destructive to thinking. Such a committee could, conceptually, function as a place where physicians, pharmacologists, pharmacists, and nurses exchange information on the latest forms of therapy and where they are stimulated to learn more. Unfortunately, committees of this sort are to a major extent involved in economic matters. It is true that “more” (or the most costly) is not, therefore, “better” but neither is it the case that “least” (or the least expensive) is!

Physicians who must defend why they deviated from EBM in a particular case are left with lesser amounts of elbowroom in decision-making. They are limited in what they can order when it comes to laboratory work, x-rays, consultations, or medications. Physicians – who are held liable for not doing something – are faced with MCOs questioning why it is that they want to do something. In many states MCOs under the Employee Retirement Income Security Act (ERISA) cannot be sued – physicians can. I would claim that the secretary who has refused my physician permission for an MRI or insisted that 20 mg rather than 40 mg of a certain medication will be sufficient is engaged in the practice of medicine without a license. Overwhelmingly, healthcare management organizations (HMOs) and MCOs love EBM – not so much because it will improve patient care but because it will increase the profit margin of the stockholders. Let us be honest: The primary interest of MCOs, insurance companies, and similar institutions is not the patient's good (except when it becomes obviously bad enough that it is no longer competitive) but making as much profit as possible. Physicians, on the other hand, if they are to be true to their oath, are interested in the patient's good even if that good is expensive.

There are, then, several differing interests involved:

• The physician's interest is above all, hopefully, the good of the patient and not the profit of the company. (Nevertheless, when faced with incessant and often changing MCO requirements based on the abstract use of EBM, it is not difficult, as mentioned above, to cave in and accept “the system” as the norm.)
• The employer is interested in saving as much cost as possible in buying a given healthcare plan for its employees.
• The patient is interested in the best “quality” of medical care available. This by no means implies that the more something costs, the better it is. But the opposite is equally and more frequently the case.

The reason most of us go to a physician, other than to have a slip signed, is because we are ill, vulnerable, and, often, in pain. At such times many of us will hope that the physician will advise us with our interest in mind. Our autonomy is distorted and often we do not wish to participate in making decisions. We hope that our physicians will not advise or treat us on the basis of MCO restrictions but because they feel that what is advised is medically indicated. Patients in general want their physicians to have enough elbowroom from their MCO or HMO, even though that is shrinking daily.

A physician who knows of an effective treatment given often and with relatively good results, but who withholds or downplays this information from the patient because the MCO finds that providing this service, while it may save a life, decreases the income of the stockholder, is acting unethically. For millennia, patients have assumed that physicians will act on their behalf and set other considerations aside. Expectations do not create duties. But whenever an expectation is held by one and in general is faithfully executed by the other (especially when this has happened over millennia), an obligation to do so – or to inform the public otherwise – is not unreasonable. This age-old assumption, to our everlasting shame, may be changing: Patients are beginning (for diverse and often justifiable reasons) to have less and less trust in the medical profession as a whole and in their physician in particular.[9,10]

EBM, when it is properly followed and when the physician has the right to deviate from it for good reasons, can be used as a tool for education. It rarely is. The question “Why are you giving him ‘X,’” when answered with “Because that is what the MCO tells us to do,” is a demeaning and anti-intellectual answer. The problem is that the system is blamed, without realizing that a social system is not “an act of God or nature” but something we constructed together and that can, therefore, change. A few sentences from the Holocaust literature are apt:

Today we blame many of our social ills (which, in the United States, include a lack of access for a large part of the population and inadequate insurance for the rest) on the system. That is quite true and may serve as an explanation. However, it does not serve as an excuse. In the Nazi era there was one high official in the railroad who was responsible for the train schedules in the East. All he “did” was make schedules for trains to go to Warsaw, Lodz, and, of course, Treblinka, Sobibor, Auschwitz II, etc. Their destination, he felt, was none of his business. He was part of a system. The comparison is not so far-fetched. At most clinics, MCOs, and HMOs in the United States, the secretary will send the uninsured sick old lady away before any healthcare professional even knows that she is present. Likewise, we physicians living in comfortable middle-class homes do not see the poverty, hunger, and misery virtually next door. It was not the secretary who sent a sick, old lady away; it was not the doctor who ultimately did not see the lady; it is not us who ignore poverty, ignorance, and want; it is the system. As the quotation above shows, atrocities, when performed by “the system,” become the norm and the person engaged in them comes to accept them as a norm. In effect, they have surrendered their humanity and given up their moral agency.

Essentially there are two sorts of social systems: One is a “natural system,” that is, one imposed on us by nature. Here, by using our biological capacities, we may “push the envelope,” wiping out some diseases and curing others but recognizing many others as beyond our capacity today. Modifying that natural envelope allows us to change the shape but still leaves the natural, albeit newer, envelope for us to deal with. The other is a social system that we ourselves have created. It is quite a different system for it has been established by us and can be changed fairly well by us. This sort of social system includes the distribution of wealth, “honors,” and emoluments as well as – and most essentially – how we as a society deal with the horrendous poverty and lack of healthcare in the United States as well as what we condescendingly call the “developing nations.”

It is entirely possible to change a social system – a sentence that should be even truer in a democracy. EBM is heedless to personal or social circumstances, uninterested in psychological factors, but spawned by the belief that what physicians deal with is disease and not patients who happened to be afflicted with a particular disease. “A herniorrhaphy patient can go home in 1 or 2 days” – is that really true? It is probably true if the patient lives in a middle-class suburb with a spouse and adequate sanitation. But is it true for a 55-year-old man who lives in a rat-infested “project” building on the fifth floor and without a functioning elevator? EBM tends to take the critical faculty of judgment away from the physician while often still holding him accountable when the herniorrhaphy breaks down.

It is useless to try to punish people for the outcome of such a system. The white, middle-class, male American is not culpable for slavery, for the past treatment of women, or for the deplorable treatment of minorities today. Guilt or culpability is judged on an individual basis, and I have participated in none of these – perhaps because I lacked the opportunity? But as a member of a society that did these tragic things and profited from such things in the past and in many respects still does today, I must assume the obligation of trying to ameliorate and abolish conditions from which – wish it or not – I profit daily. Therefore, we all are responsible for doing our part to see that crass inequities are abolished, for if we fail to do so we, indeed, become guilty. Depending upon our profession, how we do it may be different, but at least we cannot sit quietly by while people in Bosnia, Uganda, Iraq, or the United States are grossly mistreated or while patient care is reduced to a rigid stereotypic formula. Fighting “the system” by your own methods will not work; only getting together and saying a united “NO” can accomplish a change from a system in which 5% of this good earth's inhabitants own 90% of all property. EBM adds a little contribution against social justice by making it difficult to step outside “the system” and see that this poor, sick lady or those hungry, poverty-stricken, and desperate people get care.

All of this basically means that we must craft what Margalit calls, in The Decent Society, a society that aims to minimize the disparagement of its members by poverty, lack of decent housing, and healthcare and the lack of all those things that people need in order to live with self-respect.[12] In many ways, EBM disparages the physician who must follow a protocol that he or she knows may not be in the patient's best interest and consequently decreases the physician's self-respect. We are a strange society: On the one hand we have made autonomy into the supreme virtue; on the other we have created instruments which force others (physicians) to act in ways they find suboptimal. We have created a society that worships autonomy and then turns around and prescribes to their professionals what they can do.

There are several advantages and a disadvantage to EBM. The proof of the pudding, so to speak, is in the eating! When properly applied, EBM and its ilk could have the following advantages:

• When reliable and properly applied to an individual who belongs to that particular group (eg, ethnicity, gender, economic standing, etc.) EBM protocols can be helpful, and sometimes necessary, to a particular patient. But EBM is, I suspect, quite unnecessary for a well-trained and thoughtful physician.
• When used with discretion, EBM is useful as a check-sheet that makes sure that nothing vital has been overlooked.
• The process of developing EBM, if used correctly and with the patient's good as the most important consideration, may be most useful in the educative process. Suggesting that EBM is a protocol into which a patient with a given disease can simply be plugged destroys any educational value that developing such an instrument ever had.

To me, as a bioethicist and (long ago) a physician who has observed the evolution of EBM, I am impressed with the danger to physicians, patients, the educative process, and, ultimately, to the behavior it encourages. Mindless reliance on EBM does exactly what we do not want our students to do: convert what is a suffering human being, with a unique personal life-history, into a specimen of pathophysiology or a heart murmur. When utilized improperly:

• EBM is basically anti-intellectual and is “doing-” rather than “thinking-” oriented in the sense that it promotes mindless algorithm. I will claim that among a physician's most important tasks is thinking. EBM protocols – which by their nature are check-sheets – only rarely teach students or attendings to think; indeed, they discourage it.
• EBM protocols tend to be looked upon as “the right way to do things” instead of as “the current (minimally effective) way to do things.” They violate Hume's and Kant's rule which in essence states that one cannot determine what should be the case by knowing what is the case – the latter being necessary, but not sufficient.
• EBM protocols, together with our growing technical ability, increasingly become obstacles to our thinking and ultimately interfere with the patient-physician relationship of trust, a critical component of good care.
• EBM protocols start out being considered as guideposts and end up being considered as straightjackets – and straightjackets that are welcomed by many physicians (one actually told me that he was enthusiastic about them because they saved time and did not require him or her to think!).
• Worse than that – and even though institutions will deny this – the institution looks upon these policies not as guidelines but as straightjackets. Physicians who do not follow these “guidelines” can then be called on the carpet – not because the patient suffered but because the institution lost money.
• When an official EBM is proclaimed, physicians often are afraid to insist upon elbowroom in their treatment. This is, in my view, a grave mistake and one that is demeaning and disparaging to the profession which is supposed to treat the ill according to their “oaths,” all of which state that ethnicity, political, national, or financial circumstances must not enter into the decisions made.[13]

Physicians, just like garbage collectors or police officers, are socialized to believe that they have certain obligations. Society expects it of them, and while an expectation does not create an obligation, a reasonable expectation discharged over the years as though it were indeed an obligation denotes that it has been tacitly accepted as such. Physicians, in fact, have always had the obligation to be the patient's advocate and, in general, they have been. But today we are creating a society in which physicians are torn by what they feel are their obligations (1) to their employer and (2) to their patients. The “for profit” MCO really does not have this quandary. The chief ethical obligation of the CEO is to see that the stockholders are profited. That is hardly the aim of patients or physicians and carries within it at least the seed of conflict.

Physicians could – if they understood solidarity and did not merely pay lip service to a concept they did not understand – make certain demands for good patient care (and above all plans that involve enough time to spend with patients) and, if rebuffed, start with incremental strikes. One can begin by refusing to fill out forms and continue by not seeing patients for trivial things – and I would bet that further escalation would not need to take place. If it did, “treatment of well-defined ‘emergencies only’” would, I believe, prove successful in an extremely short time. The physician's demands should mainly be patient-oriented, which would fairly well assure the sympathy of the public. Although most physicians' organizations have rather good plans for universal healthcare, these various plans by internists, family practitioners, etc. will be ignored, whereas a more broadly agreed upon plan well worked out in advance and presented to legislators and other representatives will, especially if the media are involved, be taken seriously. To our everlasting shame, the two largest associations of bioethicists in this country have refused to take a stand. One of these organizations finally voted that it would begin taking stands, but not on things that concerned the population at large – only on university conflicts, salaries, and other things that profit the organizations' members but fail to help patients or society.

As I watched EBM protocols develop, I was struck by the willingness of intelligent people to be regimented. At the various meetings, the nature of EBM protocols and their potential for abuse were not the topic of discussion. Rather, physicians were narrowly concerned that a particular antibiotic could be used, etc. They failed to see the looming threat that these “helpful guidelines” of today would become the straightjackets of tomorrow that must be obeyed. And, when 2 or 3 years later this is exactly what happened, they grumbled. But because it was “the system” they were not at fault. Soon they even gave up grumbling and, the more thoughtful of them, being thoroughly disenchanted, retired early.

Some years ago, a hospital which was the main teaching hospital at a university where I once taught started to draft protocols for certain diseases. I happened to be present when a pneumonia protocol was agreed to, and I was mystified that sputum cultures were not part of the protocols. Hesitatingly (since I had not done “hands-on” medicine for some time) I asked about this lack and was told that “of course, they should be part of the protocol but they're generally done wrong anyway.” Unbelievably bad logic, but there was an algorithm as to what to do and what to order. What I fear is that physicians will give in to this “system error” and, instead of fighting the system, simply comply. Instead of writing a set of orders, physicians may – after a brief examination, which certainly confirmed pneumonia but missed greatly enlarged axillary nodes – simply write down “pneumonia protocol” and go home. Patients are individuals, and while statistics are critical to good practice, they cannot be used on an individual patient who not only may fall anywhere on the Gaussian curve but who also happens to have any one of a number of illnesses that should properly modify the protocol.

I have discussed the advantages and disadvantages of EBM protocols. While it is my view that they may serve as guidelines, the danger of their becoming straightjackets is by no means trivial. Such a procedure threatens to separate the patient's uniqueness further from the physician and would support looking at the disease instead of at the patient who happens to have that disease. In making all treatment a routine, it may well decrease physicians' curiosity and cause them to overlook important incidental findings. Beyond this, the danger of using EBM protocols not mainly to help patients (and perhaps jog the physician's memory) but as a cost-saving device is deplorable. There is no doubt that costs must be held down and waste eliminated. Until that is done, starting to talk about rationing is not the problem – rationalization is.

I specifically want to thank Dr. Eike-Henner Kluge of the University of Victoria and Dr. Chris Hackler of the University of Arkansas for their valuable suggestions.