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Safety First

The pharmacogenomics revolution has a chance to change this picture. Within five years, genetic tests identifying individuals at risk for an adverse reaction will very likely be a more routine part of how new drugs are developed; after that, such tests may actually be co-marketed with new drugs.

Taking the lead are companies like Glaxo Wellcome which will soon merge with SmithKline Beecham. Glaxo signaled its commitment to the area by hiring pharmacogenomics pioneer Roses in 1997 to lead its gene research efforts. As director of the Center for Human Genetics at Duke University, Roses had a hand in tracking down the gene that causes amyotrophic lateral sclerosis (Lou Gehrig’s disease) and led the team that identified apolipoprotein E (apoE), a major genetic factor in Alzheimer’s disease.

Roses has set up a widespread network of medical-center-based programs to speed the search for disease genes. One of the first successes was creating a map of the SNPs present in the apoE gene; this development has opened up an entire new frontier in searching out genetically targeted treatments for Alzheimer’s, which has proved notoriously hard to treat.

While developing a more effective Alzheimer’s drug could take a decade, Roses expects in the next two to five years to submit for FDA approval a pharmacogenetic test for the safety of Glaxo’s anti-HIV drug Ziagen. Around 5 percent of AIDS patients have a predisposition to develop dangerous and potentially fatal hypersensitivity reactions to this medication, a rate found with other AIDS drugs as well. If the FDA approves the test, then the right 5 percent of the population will know not to take Ziagen.

That test, Roses says, will be the “proof of principle” that the genetic revolution is both smart business and good for people. He contends it will “have a revolutionary effect on the pharmaceutical industry,” dramatically changing the way the industry operates. “It will be inescapable. You cannot deny evidence-based safety testing to people taking a drug.”

Many of Roses’ peers worry that pharmacogenomics may fragment their markets in ways that could be lethal to the corporate bottom line. Roses believes otherwise, arguing that the new Ziagen test will drive far more people to Glaxo’s drug. Armed with pharmacogenetic tests for safety, he says, Glaxo’s products will have “…a huge competitive advantage….Would you pay more for a pill that is a thousand times safer?” And once that first test for Ziagen demonstrates its market, “the dominoes will start to fall,” he says. “Consumers will want it. We’re a regulated industry. Regulators will demand it.”

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Tagged: Biomedicine

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