by Karl Coplan
Frederick Tucker’s Op-Ed in today’s New York Times is worth a read. Tucker tells the story of the FDA’s interim approval of Avastin for treatment of breast cancer over the objections of an advisory committee, and Genentech’s current attempts to avoid expiration of the interim approval, despite subsequent studies showing that Avastin neither increased survival times for breast cancer victims nor improved their quality of life. With a complete lack of clinical data supporting any medical benefit of the drug, Genentech has resorted to anecdotal testimony of individual doctors and patients who believe that Avastin has had therapeutic benefits despite the lack of scientific evidence.
This matter is of interest to the environmental law community, as it presents another illustration of the complex interplay between science, politics, and agency expertise in our administrative state. Presenting the testimony of individual doctors and patients to “refute” clinical studies is roughly analogous to calling residents of New England to testify about the cold and snowy winter they just went through in order to “refute” climatological evidence of warming global temperatures. The case is also interesting because the pharmaceutical industry is an industry where business decisions ought to be based on scientific determinations about the efficacy of drugs, but in fact seems to be based on political determinations about the ability of the drug manufacturer to convince regulators and doctors of the efficacy (and safety) of the drugs in question. Other industries may be more science-dependent, and less regulator-dependent in their business decisions. If an oil exploration company digs a dry well because it relied on the hunch of its marketing branch instead of the analysis of its geophysical staff, it can’t just get the Department of the Interior to declare the well “productive” anyway, contrary to the scientific evidence.
I am very interested in how different industries incorporate the scientific method into their business decisions. Obviously, the insurance industry has very different views on climate change than does the petroleum industry or the coal industry. Any other examples come to mind?
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