As investigators in the Pharmacogenomics Research Network (PGRN), we would like to commend the FDA for sponsoring a broad and open workshop to develop perspectives from both patients and healthcare providers about returning research data and particularly genetic test results to them. Below we would like to comment on the Public Workshop. We specifically focus our comments on returning research data relevant to drug response.
We note that survey results available in the presentation slides available here <http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM489218.pdf> demonstrate that an overwhelming number of people (89 to 90%) would like data which show their risk for an adverse drug event returned to them. We also note that the respondents did not care whether the research data contain genetic test results (89%) or other types of research information (90%). We strongly endorse the survey response, and agree with the idea that research results including results from genetic tests should be returned to the public. As PGRN investigators, we would like to underscore the fact that pharmacogenomic information is frequently actionable… if not immediately, then in the future. Informing patients about their risk for adverse drug reactions or poor response to medications is important for the optimal selection and dosing of medications to treat disease. Pharmacogenomic information should be returned to patients and providers.
The PGRN and PharmGKB fostered the formation of the Clinical Pharmacogenetics Implementation Consortium, CPIC, which has a goal of translating genetic test results into actionable prescribing decisions. The goal of the consortium is to provide information to healthcare providers on how available genetic test results should be used to optimize drug therapy. CPIC brought together experts from multiple disciplines to make recommendations about drug and dose selection based on genotype/phenotype information in the literature. We feel that it is critical that there are high standards for reporting pharmacogenomic test results to providers and patients. Reports should include authoritative recommendations from scientists, ethicists, and health professionals (such as those from CPIC) on how to appropriately use the information to guide drug and dosing selection. Importantly, the quality of the test results should be high. We note that many pharmacogenomic tests are not yet ready for implementation. That is, the tests have not been validated in multiple studies, the genetic variants that alter function (causative) have not been identified, and the algorithms for guiding drug selection and dosing have not been curated or developed. These are the challenges that scientists from multidisciplinary sectors are facing and are working together to improve drug optimization based on genetic data. Finally, we suggest that data returned to health professionals should be available to patients. In addition, other lay summaries of the reports should be developed by scientists, clinicians and patients and made available.
The Hub team