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U.N.'s Burdensome Rules Continue to Defy Science
by HenryMiller (Posted 11-28-2005 08:35 PM) [View Discussion | Join Discussion | Rate Thread ]

Hartwig de Haen's letter ("Agency Seeks to Form World Food Standards," Nov. 14) unwittingly illustrates my point -- namely, the unscientific approach and lack of rigor of United Nations' institutions, programs and senior officials. Without offering a shred of evidence to bolster his assertions, he assures us that the U.N. is committed "to the contribution of biotechnology to eradicating world hunger," and to "developing standards for foods on the basis of scientific evidence and risk analysis."

The facts argue otherwise.

Like trying to build a bridge or an airplane using the incorrect value of the Greek letter "pi," when the basic assumptions that underlie a project are flawed, everything that follows is distorted. A long-standing scientific consensus and 30 years of experiments confirm that gene-splicing technology and its products are not, in fact, distinct categories amenable to generalization; gene-splicing techniques are essentially an extension, or refinement, of earlier, less precise, less predictable techniques to accomplish genetic improvement -- not unlike the improvement of automobiles' performance and safety with radial tires and disk brakes.

But the U.N.'s deliberations -- including those under the imprimatur of Codex (a creature of WHO and FAO) -- continue to defy science by devising burdensome new regulatory requirements and procedures that apply only to the pseudo-category of foods from gene-spliced organisms. This turns the logic of regulation on its head: In the U.N.'s distorted world of regulatory oversight, there is an inverse relationship between degree of regulation and risk. The result is vastly inflated R&D costs and diminished diffusion of superior techniques and products -- especially to poorer countries, which need them desperately.

It is easy to declare support for the U.N.'s Millennium Development Goals. What's harder is to resist activists' placing anti-scientific, politically motivated obstacles in the way of meeting them. At this, the U.N. and Mr. de Haen are failing miserably.

       ABOUT THE AUTHOR
Dr. Henry I. Miller is an academic researcher, author and commentator. He graduated from the Massachusetts Institute of Technology with a Bachelor of Science degree in Life Sciences and attended the University of California, San Diego, receiving the M.S. (Molecular Biology) and M.D. degrees. After completing his clinical training in internal medicine as a Clinical Fellow in Medicine at Harvard Medical School, Dr. Miller was a Research Associate in the laboratory of Philip Leder at the National Institutes of Health.

Dr. Miller joined the FDA in 1979 and served in a number of posts involved with the new biotechnology, among them Special Assistant to the FDA Commissioner and founding director of the FDA's Office of Biotechnology. During his government service, Dr. Miller wrote and lectured frequently on the regulatory requirements for biotechnology products, and participated frequently on various expert and policy panels as a representative of the FDA or the US government. As the FDA's contact person for the Securities and Exchange Commission, he reviewed the accuracy of claims made by companies in their prospectuses about the likelihood and timing of drug approvals.

Dr. Miller is currently at Stanford University, where he is a fellow at the Hoover Institution. His research focuses on the relationship between science and regulation, the costs and benefits of government regulation, models for regulatory reform, and federal and international oversight of biotechnology. Other research areas include various aspects of bioterrorism and the need for better oversight of nutritional supplements.

Dr. Miller is the author of more four hundred articles in scholarly and popular publications. He writes frequently for such publications as the Financial Times (London), Wall Street Journal, Los Angeles Times, Chicago Tribune, Washington Times, Biotechnology Law Report, Trends in Biotechnology, and Nature Biotechnology. He is the author of Policy Controversy in Biotechnology: An Insider ' s View (R.G. Landes Co. and Academic Press, 1997) and ' To America ' s Health: A Proposal to Reform the Food & Drug Administration ' (Hoover Institution Press, 2000). Dr. Miller is a director of Consumer Alert, a national consumer advocacy organization; a director of the American Council on Science and Health; an Adjunct Scholar at the Competitive Enterprise Institute; and a scientific advisor to the George C. Marshall Institute.

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