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Health Affairs, 28, no. 3 (2009):
926-927
doi: 10.1377/hlthaff.28.3.926 © 2009 by Project HOPE |
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Letters |
Evidence Dilemma: The Authors Respond
We appreciate Neil Holtzman’s comment on our paper (Nov/Dec 09)—specifically, his criticism of our statement that "setting the evidence threshold too high could be a disincentive for investments in research and development." We call attention to the second part of the same paragraph, in which we state: "On the other hand, an undefined or excessively low threshold could encourage innovations that provide poor value and prematurely move technologies with unsubstantiated claims toward medical practice, with adverse consequences for the health system and its patients." Currently, as we stated in our paper, this low threshold for genomic applications to enter clinical practice "approximates the current state of affairs in the United States for many laboratory developed tests (LDTs)." In fact, we do not advocate for lowering the evidence standards, as Holtzman implies. If anything, we would like to raise the evidence standards to guard against some of the issues that both Holtzman and we are concerned about. The current Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative, sponsored by the Centers for Disease Control and Prevention, is an example of a contemporary effort to refine and apply evidentiary thresholds for clinical validity and utility for different types of genomic applications in practice. A methodology paper and three evidence-based recommendations in cancer genomic applications were published in January 2009.1 We also agree with Kathy Hudson in developing and implementing new ways of translation research and evaluation that allow us to move beyond our current dilemma in genomic medicine.2
Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia
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- S.M. Teutsch et al., "The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Initiative: Methods of the EGAPP Working Group," Genetics in Medicine 11, no. 1 (2009): 3–14[Web of Science][Medline]; EGAPP Working Group, "Recommendations from the EGAPP Working Group: Can UGT1A1 Genotyping Reduce Morbidity and Mortality in Patients with Metastatic Colorectal Cancer Treated with Irinotecan?" Genetics in Medicine 11, no. 1 (2009): 15–20[Web of Science][Medline]; EGAPP Working Group, "Recommendations from the EGAPP Working Group: Genetic Testing Strategies in Newly Diagnosed Individuals with Colorectal Cancer Aimed at Reducing Morbidity and Mortality from Lynch Syndrome in Relatives," Genetics in Medicine 11, no. 1 (2009): 35–41[Web of Science][Medline]; and EGAPP Working Group, "Recommendations from the EGAPP Working Group: Can Tumor Gene Expression Profiling Improve Outcomes in Patients with Breast Cancer?" Genetics in Medicine 11, no. 1 (2009): 66–73.[Web of Science][Medline]
- K. Hudson, "The Health Benefits of Genomics: Out with the Old, In with the New," Health Affairs 27, no. 6 (2008): 1612–1615.
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