Biomedical Industrial Sponsorship and Its Impact on the Medical Literature

Abstract

The pharmaceutical industry plays a vital role in the development of new drugs. The industry is involved at two levels. The first is in the design and discovery of new drugs, which may occur in their own laboratories or in the university environment. The second is the research and development that brings a drug onto the market as a result of clinical trials; the latter take place in the clinic in both university and nonuniversity institutions and, for the most part, are sponsored by industry. The pharmaceutical industry is enormous, with an estimated annual worldwide budget of $6 billion for drug development. To put this into perspective, the market for prescription drugs in the United States was $130 billion during the year 2000, and in 2001 it was $150 billion plus £7 billion in the United Kingdom. 1,2 The cost of bringing each new drug to market is estimated to range from $250 million to $800 million; and it is estimated that, on average, each day’s delay in U.S. Food and Drug Administration (FDA) approval of a new drug costs $1 million per day. 2 This is an enormous expenditure, but of course the potential profits are also enormous. Without question many drugs of significant value to mankind have arisen from the endeavors of the pharmaceutical industry. Nevertheless, it has also resulted in many drugs of the same type with similar efficacy and similar safety profiles (‘‘me too’’ drugs) competing for the same population of patients. In the United Kingdom, the annual expenditure of the pharmaceutical industry on research, both basic and clinical, is £3.3 billion; and 90% of all clinical drug trials are financed by the pharmaceutical industry. 3 If most drug trials are sponsored by the pharma