Ethics and Evidence-Based Medicine: Is There a Conflict?

Erich H. Loewy, MD

Disclosures
In This Article

Towards a More Group-Appropriate Application

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!

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