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Pharmaceutical Evolution: Clinical Selection versus Intelligent Design
Charles Darwin’s opponents sometimes advance an alternative theory to evolution by natural selection. It is known as “Intelligent Design”. They argue that the human eye, a favourite example, is so exquisite that it cannot be the mere consequence of natural selection acting on random heritable variation. Instead, there must be an Intelligent Designer. Most biological scientists view Intelligent Design as a fallacy. The argument also irritates squid, whose magnificent eyes avoid some bad design features of the human model.
There is an analogous divergence when it comes to pharmaceutical innovation. On one hand, many successful drugs appear to have been Intelligently Designed for a specific therapeutic use. Their designers exist, and the few I have met seem ferociously intelligent. Here, Gleevec/imatinib plays the role that the human eye does for creationists. On the other hand, luck is often important and drugs’ natural environment, the clinic, can select in a way that the Intelligent Designers would not have anticipated.
In the working paper, I argue that there is a problematic tendency to over-estimate the importance of Intelligent Design versus Clinical Selection in pharmaceutical innovation. Intelligent Design is the public face of commercial R&D. It dominates academic biomedical science. It influences drug regulators and doctors. It aligns with the most valuable kinds of intellectual property, and so influences pricing and reimbursement. In contrast, things are made difficult for late-stage serendipity, for the real-word experiences of patients and doctors, and for creative users, who, in my view, already do much of the innovative heavy lifting. The skew is reflected in relative over-investment in “molecular reductionism”, which often lacks predictive validity, and in relative under-investment in optimizing the use of drugs in their natural environment. The skew can also squeeze the pharmacological variation on which Clinical Selection acts, slowing the rate of therapeutic evolution.
© Association of the British Pharmaceutical Industry 2015
This paper was first published as “Pharmaceutical Evolution: Clinical Selection versus Intelligent Design” in the R&D Sourcebook dated 2015. This reprint is with kind permission of the publisher.