Analysis

Pharmaceutical research and development: what do we get for all that money?

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e4348 (Published 07 August 2012) Cite this as: BMJ 2012;345:e4348
  1. Donald W Light, professor 1,
  2. Joel R Lexchin, professor2
  1. 1Department of Psychiatry, University of Medicine and Dentistry of New Jersey, 2250 Chapel Avenue, Cherry Hill, NJ 08002, USA
  2. 2York University School of Health Policy and Management, Toronto, Ontario, Canada
  1. Correspondence to: D W Light dlight{at}princeton.edu
  • Accepted 18 May 2012

Data indicate that the widely touted “innovation crisis” in pharmaceuticals is a myth. The real innovation crisis, say Donald Light and Joel Lexchin, stems from current incentives that reward companies for developing large numbers of new drugs with few clinical advantages over existing ones

Since the early 2000s, industry leaders, observers, and policy makers have been declaring that there is an innovation crisis in pharmaceutical research. A 2002 front page investigation by the Wall Street Journal reported, “In laboratories around the world, scientists on the hunt for new drugs are coming up dry . . . The $400 billion a year drug industry is suddenly in serious trouble.”1 Four years later, a US Government Accounting Office assessment of new drug development reported that “over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining.”2 In 2010, Morgan Stanley reported that top executives felt they could not “beat the innovation crisis” and proposed that the best way to deal with “a decade of dismal R&D returns” was for the major companies to stop trying to discover new drugs and buy into discoveries by others.3 Such reports continue and raise the spectre that the pipeline for new drugs will soon run dry and we will be left to the mercies of whatever ills befall us.4

The “innovation crisis” myth

The constant production of reports and articles about the so called innovation crisis rests on the decline in new molecular entities (defined as “an active ingredient that has never been marketed . . . in any form”5) since a spike in 1996 that resulted from the clearance of a backlog of applications after large user fees from companies were introduced (fig 1). This decline ended in …

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