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Darwin's Medicine blog

Professor Brian D Smith is an authority on the pharmaceutical industry and works at SDA Bocconi University and Hertfordshire Business School.

The death of deference

We are entering an age when authority matters less

Sometimes, events in our industry provoke a feeling of déjà vu and remind me of Mark Twain's wise adage that history doesn't repeat itself but it does rhyme. The recent news that the FDA has delayed its decision about Sarepta Therapeutic's eteplirsen did just that.

This situation is remarkable because of the contest it represents between, on the one side, patient groups representing Duchenne's and, on the other, those who fear for the precedents that might be set and the independence of the regulatory approval process. If I'd have told you some years ago that the FDA would be even considering a drug with a single, small study then you may well have been incredulous, so that it says something important about the way our industry is evolving. It also illustrates the way that our industry's current burst of evolutionary change resembles the events of its history. As usual, let me digress a little into my research before I return to the practical implications for today.

The science-based industry we work in today has evolved over the last 150 years or so. Prior to that, the apothecary business model dominated the industry and had done for about 600 years. I've written elsewhere about the Victorian convergence of trends, which led to this dramatic extinction of one model and the emergence of another, because we see many echoes of it in today's transformation of the industry. But the eteplirsen situation is a particularly strong illustration of one of the less discussed forces shaping our industry, one whose parallels with our industry's birth period have important lessons.

Historians call the late 19th century the second industrial revolution. Most of the factors that earn that label are technological: steam ships, electricity, telephones and so on. However, these were complemented by contemporaneous social factors; mass education, rising middle classes and early globalisation are among these. One social factor,  important to the rise of the life science industry, that is rarely discussed was disenchantment. This is the idea, popularised by sociologist Max Weber, of a societal shift towards rational, secularised values and away from religious mysticism. Although this shift was pervasive and far-reaching, we see it especially in attitudes towards medicines, where folk cures and 'secret remedies' became devalued in favour of products with some technological foundation. Early research-led firms adapted to this and so disenchantment contributed to the evolutionary transformation as much as, for  example, organic chemistry and germ theory did.

Doctors routinely report being challenged by their patients, payers' decisions are disputed by patient advocacy groups

In my work, I discern a 21st century parallel to disenchantment, namely the 'death of deference'. I've not been able to find the source of this phrase but it is very widely discussed in fields ranging from organisational leadership to medical care. In essence, it describes a societal shift away from automatic respect for authority and towards belief in individual power. Examples in our industry are not hard to find. Doctors routinely report being challenged by their patients, health economic assessments are contested by companies, payers' decisions are disputed by patient advocacy groups. The eteplirsen situation is simply one further illustration of this trend. The death of deference is as important a factor in the evolution of our industry as disenchantment was in its birth.

Now, let me return to the practical implications for life science companies. It is not difficult to see both threats and opportunities. Already, we see companies harnessing the lack of deference of patient groups to influence payers. We also see society's lack of deference towards large life science companies contributing to our sector's often-poor industry reputation. Our ancestors reacted to disenchantment by understanding and adapting to that shift. The challenge for today's industry leaders is to adapt similarly by developing the capabilities to understand the death of deference, exploit its positive implications and defend against the negatives. From my perspective, many life science firms do not appear to be well-suited for this. This seems especially true of the most research-oriented firms. Deference lies in the domain of social science, while industry executives are much more comfortable in the realm of natural sciences. Their first instinct is to ask for the numbers, which is to ignore the epistemological breadth needed to understand social phenomena.

But life science companies - and regulators and payers - will have to adapt to the death of deference; evolutionary pressures will make them. The only questions are who will adapt first, how quickly and how well they will do this and which firms will be selected against by this inexorable pressure. Life science firms that don't adapt to the death of deference, like those that didn't adapt to disenchantment, will become extinct.

17th June 2016

From: Healthcare

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