Medco Announces Research Collaboration with FDA Focused on Personalized Medicine
News Aug 19, 2008
Medco Health Solutions, Inc. and the Food and Drug Administration (FDA) have entered into a research partnership to study genetic testing and the impact of genetics on the efficacy of prescription drugs.
The announcement adds credence to the emerging science of personalized medicine and will expand the body of evidence for the consideration of personal genetics in how doctors prescribe drugs.
Under the partnership, Medco and the FDA will jointly develop research projects, programs and strategies in the area of pharmacogenomics, collectively aimed at improving patient health and quality in the delivery of care.\
Pharmacogenomics is the science of capturing a patient's genetic information to help predict how a person is likely to respond to a wide variety of drugs, including commonly used prescriptions such as pain relievers, anticoagulants, and cancer drugs. This information has a bearing on what drug is selected and may help optimize doses for particular drugs. Commercial tests are currently available to identify the appropriateness of specific drug treatments based upon a patient's genetic profile.
"An increasing number of drugs are including genetic information in their labels and we're finding out how genes affect some drugs that have been widely used for generations," said Medco's Chief Medical Officer Dr. Robert Epstein. "Studying this field can advance pharmacy care to remove some of the trial and error in how medications are prescribed."
The research agreement extends to Aug. 31, 2010, during which time Medco will deliver a series of reports to the FDA about pharmacogenomic testing. The topics to be studied will address the safety of prescription drugs, physician participation in pharmacogenomics testing, the usefulness of the tests in prescribing, and quantifying prescription information about drugs that have genetic information in their labels.
Medco's reports will be derived from clinical settings, including one that will examine whether physicians are willing to change the dose of a prescription based on a genetic test result. Medco's database of pharmacy claims will supply a large portion of the data to be used in the reports for the FDA.
Medco plans on submitting portions of the research from this partnership to peer-reviewed journals for publication with an eye on building the body of evidence supporting the value of these tests.
Medco has existing research collaborations with Mayo Clinic studying genetic consideration in the use of warfarin, and with LabCorp regarding breast cancer patients using tamoxifen. Completion of the tamoxifen study is expected this year and the warfarin study is anticipated next year. The company anticipates additional development partnerships with private companies, academic institutions and other health care entities.