History of Project

Aims and Purposes (August 2014):

We (Amar Bhidé, Srikant Datar, and Katherine McCaffrey) with the generous support of David Roux) have started a project to compile and analyze detailed case histories of the 100 most significant medical innovations in the last quarter of the 20th century. Our project has both practical and scholarly goals: Growing expenditures on medical research and health care without commensurate benefits are now regarded as a serious issue. The problem has been traced to several causes. These include scientific norms that discourage replication of results and encourage publication of ambiguous findings; intellectual property, regulatory, and reimbursement regimes that encourage low-risk and low-impact commercial development; and, the possibility that much of the low-hanging fruit from earlier scientific breakthroughs (such as the disease theory and the discovery of antibiotics) has already been harvested whereas the benefits of recent breakthroughs (for instance in genomics) are yet to come.

Case studies documenting how similar problems were overcome in the past can provide reminders of forgotten solutions. And, for problems that are unprecedented, historical analyses may improve our understanding of why these problems did not previously arise and suggest ideas for what might be done to solve them now.

Studying “who did what, when and why” should be particularly useful in addressing problems of bottlenecks and linkages. Scholars of technological innovation have shown that the successful development and widespread use of new products and services is the result of extended interactions between many individuals and organizations. These include scientists, engineers, designers, marketers, financiers, regulators, and not the least, users, who contribute different kinds of skills, knowledge, and resources and solve related but different problems. Technological advances are thus the result of what one of us (Amar) has previously called an ongoing, massively multiplayer game.

Bottlenecks and incongruencies are inevitable in such a game. In medicine, for instance, fundamental scientific breakthroughs may run ahead of the development of treatments. And the best treatments under well-controlled experimental conditions may be inferior in large-scale deployment (for instance, because of inadequate mechanisms to ensure patient compliance). Case studies encompassing multiple players and how they interacted with each other and over time to solve resolve bottlenecks and incongruencies should provide useful rules of thumb about effective rules for reforming the current medical advances game.

More broadly, studying medical advances could improve our understanding of “useful knowledge.” Scholars of the history of technology like Vincenti have persuasively argued that engineering is not merely applied science, although it often draws on – and contributes to — the natural sciences. Natural sciences focus on discovering “how the world works” in ways that may not be suited to fields such as engineering, medicine, business, education, and public administration, whose principal purpose is to develop artifacts that don’t exist in nature and are intended to make the world a better place. Thus both the natural sciences and fields of useful knowledge may aspire to be evidence-based, but the kind of data collected and how it is used can be materially different.

In medicine, for instance, Gawande’s WHO team blended expert hypotheses with rough and ready iterative testing to develop surgical checklists. Medical devices are also developed through similar processes. These would not be considered good practice in traditional scientific research.

Understanding and highlighting the distinctive features of useful medical research (as has already been done in engineering) should help prevent the dogmatic misapplication of the scientific method and possibly improve appropriate alternative practices. Moreover, the benefits could extend beyond medicine into fields such as economic development and financial regulation. The recent fashion for randomized experiments in the social sciences, if not appropriately bounded, has the potential for considerable waste of resources and even outright harm.