Managing the Medical Arms Race: Public Policy and Medical Device Innovation.

This book tackles an often-neglected aspect of the medical industrial complex: issues regarding innovation and dissemination of medical devices. This is an interesting arena in which to examine the interplay between private enterprise and public policy issues such as access to life-sustaining machines or protection from fraudulent claims or unsafe products as well as government's roles in establishing policy (e.g., as a funder of research and development, third-party payer, and watch-dog protection agency). Professor Foote adopts a simple two- dimensional framework for her analysis, categorizing policies and legal actions by the dominant direction of their effect (i.e., either enhancing or inhibiting medical device proliferation) and the point of their strongest impact (i.e., either innovative research and development or dissemination of the finished product).

She uses a quasi-historical-legal approach to establish her thesis, illustrated with a few key examples of medical devices which have had a particularly profound impact on public attitudes and policies, e.g., the Dalkon Shield contraceptive device and pace-makers and artificial hearts. She argues that medical devices have had an ambiguous "step-child" status which has contributed to the lack of specific policy focus. Namely, since devices are not really "drugs", they do not fit well under the statutes governing the jurisdiction of the Federal Drug Agency. Since they involve engineering and practical applications rather than basic sciences, the National Institutes of Health have not been very interested in supporting their research and development. And payers such as Medicare have either focused on paying for broad categories of treatments without regard to which device or have passively paid whatever was charged. These practices as a set contributed to a lethargy regarding efficiency and quality considerations both for private enterprise as well as public policy. At the same time, changing legal practices (e.g., class action suits and product liability cases) coupled with a series of well-publicized product failures and accusations of fraudulent practices brought new interest in oversight and accountability for medical devices.

While the concentration on a few illustrative cases makes the overall thesis a little less compelling, Professor Foote poses some thoughtful questions and insights into the political environment which drives policy to aid innovation in some cases and to suppress it in others.

Ann Barry Flood
Dartmouth Medical School