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71 Tul. L. Rev. 1211 (1996-1997)
Commercialization of Genetic Testing Services: The FDA, Market Forces, and Biological Tarot Cards

handle is hein.journals/tulr71 and id is 1231 raw text is: Commercialization of Genetic Testing Services: The FDA, Market Forces, and Biological Tarot Cards Michael J. Malinowski Robin J.R. Blatt* Many women fear being diagnosed with breast cancer, and rightfully so. Despite the capabilities of modern medicine, the cumulative lifetime risk of getting the disease has risen to one in eight and, despite decades of research, no cures exist. In this Article, the authors explore the commercialization of so-called breast cancer gene tests, based upon genetic alterations linked to the disease. Although the authorsfully address this specific technology, they use what constitutes the seminal case of predictive genetic testing to analyze the adequacy of the existing regulatory framework The authors conclude that the present regulatory system is inadequate and places a dangerous amount of reliance on primary care physicians. Their conclusion is grounded in the observation that most primary care physicians lack sufficient knowledge about this evolving investigative technology-which is highly subject to misinterpretation, and, though potentially helpful to some high risk patients, offers questionable clinical value for the general public. The authors set forth numerous proposals to promote both the quality and clinical value of predictive genetic testing so that it conforms to public health standards and can be properly integrated as a reliable component of medical care in specific situations. I. INTRODUCMION .......................................................................... 1212 II. TODAY'S TECHNOLOGY, YESTERDAY'S REGULATIONS ............ 1220 A. Overview of Genetic Testing Capabilities ....................... 1222 B. Existing Regulations ........................................................ 1229 © Copyright 1997 TuLANE LAw REviEw; Michael J. Malinowski, J.D.; and Robin J.R. Blatt, M.P.H., R.N., Coordinator, Massachusetts Genetics Program, Department of Public Health. * The authors are members of the faculty of the Eunice Kennedy Shriver Center for Mental Retardation. The opinions expressed are solely the authors' unless attributed to others and are in no way attributable to any of the institutions with which they are affiliated. Appreciation is due to the law firm of Kirkpatrick & Lockhart LLP for supporting this project and to our colleagues for their helpful suggestions and other contributions, including Maureen O'Rourke and members of the Massachusetts Legislature's Special Committee on Genetic Information Policy. Our special appreciation to Jan Platner, J.D., Executive Director of the Massachusetts Breast Cancer Coalition, and the others who shared their professional and personal experiences with the issues addressed in this Article. We also thank Patricia Murphy, M.D. with OncorMed, Inc., and Brian Murphy, Ph.D. with Myriad Genetic Laboratories, Inc., for reviewing an earlier version of this Article and sharing their vast practical knowledge. In addition, we acknowledge the contribution of Terenia Guill and Jana Grauberger and their colleagues at the TULANE LAW REVIEW. 1211

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