Article by Michael J. Malinowski and 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 authors fully 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.
About the Author
Michael J. Malinowski; Robin J.R. Blatt. 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.
Citation
71 Tul. L. Rev. 1211 (1997)