Magazine article Drug Topics

Personalized Medicine No Longer Science Fiction

Magazine article Drug Topics

Personalized Medicine No Longer Science Fiction

Article excerpt

CLINICAL PRACTICE

It's time to start brushing up on those basic genetics courses you had in college. The long-touted and much-doubted day of personalized pharmaceuticals has already dawned. "Genomics is becoming mainstream," said David Witmer, director of professional practice and scientific affairs for ASHP. "We're still on the early side, but we are all going to need a deeper understanding of genetics for daily practice. A lot of pharmacists are going to have to refresh their skills."

How mainstream? Genentech has already won approval for an anti-- cancer drug, Herceptin (trastuzumab), which is effective only against the 25% to 33% of breast tumors with a specific genetic makeup. Most women get no benefit from the drug, which has been associated with cardiac problems. Genentech also markets a genetic test that identifies the minority of patients for whom the drug may be effective.

The Mayo Clinic uses a blood test to identify the 10% of childhood leukemia patients whose genome makes them poor metabolizers of Purinethol (mercaptopurine, GlaxoSmithKline). Mayo has also begun an ambitious project to digitize medical records and genetic data for its six million patients. If the project goes well, researchers will be able to match individual genomic variations against specific disease characteristics and treatment outcomes.

"We're seeing the beginnings of personalized medicine with Herceptin and HIV," said Paul Oestreicher, vp. of strategic marketing and communications for Genaissance Pharmaceuticals. "We're playing catch up. Every industry you can name-cars, clothing, computers-- every industry except health care is already personalizing products. Health care has been holding on to a one-size-fits-all paradigm. Personalized medicine ensures that the right drug goes to the right patient instead of the same drug going to every patient," he said.

Genaissance is applying genomics to two tracks-safety and efficacy. On the safety side, the firm is working to identify genetic markers associated with agranulocytosis induced by the antipsychotic clozapine (Clozaril, Novartis). The drug had sales of about $350 million in 2000, Genaissance said. Sales could have been far greater, Oestreicher noted, but for the requirement that all patients undergo regular blood monitoring.

"For now, it's a 'no blood, no drug' policy even though adverse reactions are confined to a minority of patients," said Oestreicher. "If we can find the marker for agranulocytosis and screen patients before therapy begins, we can eliminate the need for blood monitoring in most patients. …

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