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SAEC Conducting Feasibility Gene-Association Study with HMO Network's E-Records

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By Turna Ray

WASHINGTON, DC – The International Serious Adverse Events Consortium is planning to use the centralized clinical data warehouse of the HMO Research Network to recruit patients for larger gene-association studies and eventually discover new genetic variations linked to hepatotoxicity, serious skin rashes, and extreme weight gain in patients taking atypical antipsychotic drugs.

The collaboration is an extension of the SAEC's ongoing effort to uncover genetic variations associated with Stevens-Johnson Syndrome, a drug-related skin condition, and drug-induced liver injury. The consortium released initial genetic findings for these conditions earlier this year [see PGx Reporter 06-03-2009].

The SAEC, established in October 2007, is a non-profit entity comprising large pharmaceutical companies, research organizations, and regulatory bodies. The US Food and Drug Administration guides the consortium with scientific and strategic input.

HMORN is a consortium of 16 health plans in the US and Israel. The network's clinical data warehouse includes information on 14 million plan members' inpatient admissions, emergency room visits, and outpatient care.

Initially, six HMORN members, including the Geisinger Center for Health Research, Group Health Research Institute, HealthPartners Research Foundation, Kaiser Permanente Center for Health Research-Southeast, Kaiser Permanente Center for Health Research-Hawaii, and Marshfield Clinic Research Foundation, will collaborate with the SAEC.

Arthur Holden, CEO of the SAEC, said that the immediate goal of the collaboration is to investigate how HMORN's vast electronic medical database may be used to identify study subjects. Currently, the consortium is not focusing on SAEs associated with any particular atypical antipsychotic drug, but simply looking at the phenotypic characteristics of patients on any kind of atypical antipsychotic medication.

"Think of this as complementary to what we've already done," Holden told Pharmacogenomics Reporter this week. According to Holden, the consortium's initial work in Stevens-Johnson Syndrome and drug-induced liver toxicity was informative but was limited by the small cohort, lacking in ethnic and geographic diversity.

Holden described the SAEC-HMORN effort as “a feasibility study” to see if electronic medical records can be useful in conducting gene association studies looking at drug-related adverse reactions. Ultimately, with the help of HMORN's electronic medical records, SAEC is hoping to recruit patients for larger genetic studies with a more diverse cohort that will enable the validation of already identified drug response gene associations, as well as the discovery of new associations.

For the first phase of the collaboration, spanning a year, each HMO will sift through the clinical profile of its members in the network's database and identify potential participants for future gene-association studies.

According to the SAEC, in this phase of the collaboration, no individual health records or health information will be released by the participating HMOs. Eventually, the SAEC plans to make freely available to all qualified researchers data generated from its investigations.

The SAEC-HMORN effort isn't necessarily unique. EMR-driven genomics studies have been ongoing in the academic setting for several years.

For example, the Electronic Medical Records and Genomics Network, called eMERGE for short, involves the Group Health Cooperative with the University of Washington, Marshfield Clinic, Mayo Clinic, Northwestern University, and Vanderbilt University. eMERGE, organized by the National Human Genome Research Institute with additional funding from the National Institute of General Medical Sciences, is conducting genome-wide analysis of gene variations and their links to human traits.

At a colloquium on personalized medicine hosted by the American Association for the Advancement of Science in Washington, DC, this week, officials from government and academia outlined several efforts to use electronic medical records to look for genes associated with disease predisposition and drug response.

According to John Glaser, senior advisor of the National Coordinator for Health Information Technology at HHS, electronic medical records could be a powerful tool for picking up post-marketing drug risk information and relative risk data. The stimulus package offers incentives to hospitals and physicians for the "meaningful" implementation of electronic health records, and Glaser is helping the federal government implement its programs.

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