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Point of View : Apr 1, 2008 ( )
Defending Pharma Companies
Innovation Is Alive and Well in the Therapeutic Drug Industry
Marc-André Gagnon’s point of view piece in the February 15 issue of GEN maintains that, by and large, pharmaceutical companies have departed from the mission of developing innovative therapeutics in favor of marketing me-too drugs so as to maximize earnings. At first blush this might seem true, but the evidence points to the contrary.
The U.S. Congressional Budget Office reported in 2006 that for U.S. pharmaceutical companies, R&D expense as a percentage of revenues from prescription drugs "has hovered around 19%"e; since the early 1990s, thereby establishing the pharmaceutical industry "as the most R&D-intensive industry in the U.S. manufacturing sector."e; In contrast, all U.S. manufacturers spend an average of barely 3.5% of product revenues on R&D.
Having presented some of the financial evidence that disputes Gagnon's argument, I must emphasize that even though the pharmaceutical industry remains committed to developing innovative therapeutics, there is substantial support for his assertion that drug companies market me-too drugs so as to maximize earnings.
A couple of examples will illustrate how difficult it is to predict the length of time it takes to develop a radically new therapeutic following a relevant seminal scientific discovery. In the 1940s it was established that one could genetically alter bacteria by means of isolated DNA. Theoretically, this discovery suggested that gene therapy might be realized sometime in the future.
On the knowledge front, recent years have witnessed significant advances in genomics and proteomics, resulting in the identification of numerous biomarkers, the elucidation of the molecular architecture of the cell, and the emergence of pharmacogenomics. We are now at the threshold of personalized medicine-targeted therapy based on genotype-dependent diagnostic results.
G. Steven Burrill has aptly summarized the potential benefits of personalized medicine: “The right drug for the right patient at the right time.” Burrill also points out the potential benefits for the developer of the medicine: smaller, quicker, and less costly clinical trials for proving efficacy in the target population, resulting in a better safety profile and a higher probability that the medicine will reach the marketplace.
J. Leslie Glick, Ph.D., is an independent corporate management advisor and a former adjunct professor of technology management in the graduate school of the University of Maryland's University College. Dr. Glick, a cofounder of the Industrial Biotechnology Association, which eventually became the Biotechnology Industry Organization, also cofounded and ran three biotech companies, one of which was Genex. E-mail: email@example.com.
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