Medco Announces Research Collaboration with FDA Focused on Personalized Medicine
FRANKLIN LAKES, N.J., Aug. 18 /PRNewswire-FirstCall/ -- Medco Health Solutions, Inc. (NYSE: MHS), the nation's leading pharmacy benefit manager, announced it 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."
Research Partnership
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's partnership with the FDA should help establish gene testing as a tool to help lower health care costs and improve the quality of care," Epstein said. "This will come from reducing waste from treatments that do not work and also from helping prevent unnecessary hospitalizations from incorrect dosages or other adverse drug events."
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.
Pharmacogenomics revolution
Unique differences in an individual's genes can cause variations in how many prescription drugs are metabolized in the body. These differences affect the speed of which a patient metabolizes medication -- affecting safety or efficacy from too high or low of a dose. Such a situation can be dangerous or potentially deadly in the case of common medications like warfarin or codeine. Approximately 30 percent of all medications are metabolized by one enzyme (CYP2D6). This opens up a far reaching range of genetic tests that could be used to determine how people will respond to a wide range of medications, including antidepressants, pain relievers, heartburn treatments, and antihistamines.
About Medco
Medco Health Solutions, Inc. (NYSE: MHS) is the nation's leading pharmacy benefit manager based on its 2007 total net revenues of more than $44 billion. Medco's prescription drug benefit programs, covering approximately one-in-five Americans, are designed to drive down the cost of pharmacy health care for private and public employers, health plans, labor unions and government agencies of all sizes, and for individuals served by the Medicare Part D Prescription Drug Program and those served by its specialty pharmacy segment, Accredo Health Group. Medco, the world's most advanced pharmacy(TM), is positioned to serve the unique needs of patients with chronic and complex conditions through its Medco Therapeutic Resource Centers(R), including its enhanced diabetes pharmacy care practice through the Liberty acquisition. Medco is the highest-ranked independent pharmacy benefit manager on the 2008 Fortune 100 list. On the Net: http://www.medco.com.
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