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Heiberg P (1897). Studier over den statistiske undersøgelsesmetode som hjælpemiddel ved terapeutiske undersøgelser [Studies on the statistical study design as an aid in therapeutic trials]. Bibliotek for Læger 89:1-40.
Key Passages
Translation
1. Heiberg stresses the problems facing the physician when choosing which medical treatment to use: the large number of choices among different drugs, how to assess benefits and harms, and whom to believe. Heiberg notes that scientific proof of the benefit of a drug can only be reached through a numerically planned trial - the statistical-therapeutic experiment. If one replaces the word ‘serum’ in Heiberg’s article with ‘humanised monoclonal antibodies’ this introduction looks surprisingly contemporary.
“I. Introduction
The time when all effective medicaments could be written on a fingernail is over. The number of efficacious medications has increased rapidly during recent years. A variety of antipyretics, soporifics, and pain-killers are at physicians’ disposal, and at the same time a completely new line of medicines has been introduced, for example, specific medicines, like different serums, developed to an exquisite degree.
Some of the more recent preparations have evident effects. No one, having administered acetyl salicylic acid for rheumatic fever only a few times, would doubt its very favourable influence on the condition of the patient. But for many other contemporary remedies this does not hold true; the effect may not be so evident and may not be that stable. The physician must rely on the experience of other physicians in order to build confidence in the drug.
Translation
But these experiences!
Some physicians provide one medical opinion, others another. Shall the physician then begin to trust the authority of one author at the expense of distrusting another? I find the latter a dangerous approach. Shall the physician then count how many authors are pros and how many are cons? For sure, an equally dangerous approach. But what then makes so many physicians refrain from judgement of a report on the astonishing potential of a new medication, even if it derives from a source in which fraud is unlikely to occur deliberately?
Among various reasons, what they answer is also true: “We have been repeatedly disappointed, and we became disappointed even when the most promising figures asserting the benefits of the new drug were produced”. From this very answer we understand the physicians’ inability to assess a numerical report on the effect of a drug because physicians are not used to working with numbers that are so large that the percentages have particular meaning. Usually, one must have the original, absolute numbers in order to be able to assess the value of the report - but the original numbers are often not published!
Especially now, when statistical examinations on serum are produced one after the other to justify the beneficial effect of the different types of serum, an attempt to clarify the requirements for statistics within the therapeutic area should be justified. Internal medicine is about to leave expectant treatment and enter direct curative treatment methods. Everywhere, on a larger or smaller scale, trials are being instituted using the guidance that experimental pathology mainly can offer to physicians. But how rarely these experiments are planned, keeping in mind the simplest requirements of a statistical therapeutic experiment!