Medicine and books: The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990
Authors: Robert A Crouch
Journal: BMJ (1998)

Harry M Marks 

Cambridge University Press, £45, pp 258 

ISBN 0 521 58142 7 

The use of statistics in clinical medical research has taken on the appearance of an article of faith. Any omission of statistical rigour from clinical research is viewed as an act of heresy, and, like the ideas of the heretic, the work of the insufficiently rigorous is banished from the scientific literature. As in all matters of faith, however, the propagation of statistical methods depends on training the next generation to follow its dictates. It should therefore not surprise us to learn that statistical methodology in medical research witnessed today is a mid-20th century phenomenon, and one that has recently come under attack. 

The issue that the historian of medicine Harry Marks addresses in his book is the process of therapeutic reform that took place, and is still taking place, in the United States. The goal of therapeutic reformers in this century has been relatively constant, and has consisted of the establishment of what Marks calls “rational therapeutics”—that is, therapeutic practice that is grounded in unbiased, scientific knowledge. 

The first half of this century, starting with the establishment of the American Medical Association’s Council on Pharmacy and Chemistry in 1906, and continuing with the US Food and Drug Administration, was the era of organisational reform, when clinical practice was directed by organisations of pharmacologists and clinicians who gathered evidence, deliberated, and published their decisions about which treatments should be in use. 

With the growth of statistical science in the years leading up to the second world war, however, the authority of professional organisations waned, and soon the era of methodological reform was set firmly in place. In contrast to the earlier part of the century, when treatments were often accepted because of the prestige of elite members of professional organisations, the establishment of rational therapeutics today comes largely from the authority and “objectivity” of statistical methodology and, in particular, from the use of the randomised controlled trial. 

Throughout Marks’s narrative, clinical research is described as a social process conducted in a manner similar to politics, in which therapeutic reformers themselves form what he calls a political community. The political nature of clinical research is most apparent when you consider the role that AIDS activism has played in increasing patient access to clinical trials, or recent American legislation mandating appropriate representation of women and minorities in clinical trials funded by the National Institutes of Health. It is here, in his claims about the political character of science, that Marks is likely to engender criticism from those who view science and the scientific method more purely as the workings of disinterested human reason, or from those who, for example, think that the reason to include sufficient women and minorities in clinical trials is ethical rather than political. 

It is hard to find fault with Marks’s outstanding book. Though readers will find his analysis controversial in places, none will be left unchallenged.