Patents and the Global Diffusion of New Drugs.

Analysis of the timing of launches of 642 new drugs in 76 countries during 1983–2002 shows that patent and price regulation regimes strongly affect how quickly new drugs become commercially available in different countries. Price regulation delays launch, while longer and more extensive patent rights accelerate it. Health policy institutions and economic and demographic factors that make markets more profitable also speed up diffusion.

The Economics of Reproducibility in Preclinical Research.

Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible-in the United States alone. We outline a framework for solutions and a plan for long-term improvements in reproducibility rates that will help to accelerate the discovery of life-saving therapies and cures.

The hidden cost of low prices: limited access to new drugs in India.

The pricing and accessibility of patent-protected drugs in low- and middle-income countries is a contentious issue in the global context. But questions about price have little meaning if a drug is not available for purchase, and the extent to which patent policy affects when (and if) new drugs become available in these countries has largely been overlooked. We examined data on the sales of 184 drugs approved by the US Food and Drug Administration between 2000 and 2009.

Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases.

Background: There has been tremendous progress over the last decade in the development of health products--drugs, vaccines, and diagnostics--for neglected diseases. There are now dozens of candidate products in the pipeline.

Purpose: Our purpose is to assess challenges that will arise in later-stage clinical development of these candidate health products and propose a strategy that would help bring the costs, risks, and finances for their clinical trials into a better, more sustainable balance.

The impact of incremental innovation in biopharmaceuticals: drug utilisation in original and supplemental indications.

Background: The apparent decrease in the rate of approval of new molecular entities has provoked extensive discussion and fears that the productivity of biopharmaceutical research and development has severely declined in recent years.

Objective: To investigate the extent to which traditional measures of innovative output neglect important innovations that occur after a drug receives initial market approval.

Methods And Results: Data on drug utilisation by diagnosis for the period 1999-2004 were combined with data on the approval histories of three important classes of drugs: ACE inhibitors, histamine H(2)-antagonists/proton-pump inhibitors, and selective serotonin/norepinephrine reuptake inhibitors.

The changing structure of the pharmaceutical industry.

Rising research and development (R&D) expenditures by pharmaceutical companies are, in part, a consequence of changing industry structure, particularly the rise of the biotechnology sector. The creation of a market for biomedical science and increased vertical competition within the industry are likely to spur innovation and raise productivity, but they also could induce socially wasteful spending and weaken academic science. With innovation increasingly dependent on financially vulnerable firms and complex contractual arrangements, R&D investment might be becoming more sensitive to price controls or other cost containment measures.

Impact of clinical trial results on national trends in alpha-blocker prescribing, 1996-2002.

Context: Research on factors that influence prescribing patterns and the extent of change produced by clinical trial findings is limited.

Objective: To examine the changes in prescribing of alpha-blockers for hypertension treatment before and after the April 2000 publication of the unfavorable Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) early termination involving the study's doxazosin mesylate arm. Changes in prescribing were considered in the context of other potential concurrent influences on medication use between 1996 and 2002, including changes in alpha-blocker drug prices, generic conversion, drug promotion, and competition.

A statistical analysis of the magnitude and composition of drug promotion in the United States in 1998.

Background: Although pharmaceutical industry marketing and other factors may influence physician decisions regarding medication prescribing in the United States, little information is available about the composition of promotional efforts by promotional mode and medication class.

Objectives: The aims of this study were to determine the magnitude of expenditures for common modes of promotion and to delineate patterns of promotional strategies for particular classes of medications.

Methods: Nationally representative data on expenditures (in US $) for the 250 most promoted medications in the United States in 1998 were available from an independent pharmaceutical market research company for the 5 most commonly used modes of promotion.