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Minnesota Gene Pool Blog

« Podcasts and videos from U of M PH genomics courses are online | Main | Citizens Council for Health Care wants to destroy NBS bloodspot archive »

Reflections from PH7200: pharmacogenomics and health disparities

Guest blogger Colleen Kingsbury reflects on pharmacogenomics and health disparities.

Of the many areas of genomics research, one area in particular is backed by tremendous financial resources. The money is behind pharmacogenomics, the application of genomics to understand variations in drug response. And the big money comes from big pharma.

The potential of this research and development is significant both in terms of benefits to individuals and margins on return for investors. Successful pharmacogenomics products may lead to reductions in the number of adverse drug reactions, creating a benefit to society. In the Public Health Genomics courses at the University of Minnesota in May 2007, Lisa Peterson of the University’s Cancer Center stated that adverse drug reactions are the fourth leading cause of death with an estimated cost of $136 billion per year in the United States.

Peterson also shared statistics on the costs of drug development. In 2001, annual worldwide expenditures on pharmaceuticals were more than $300 billion. For manufacturers, drug development is time consuming, requires significant investment and there is no guarantee that a new drug will be profitable.

Case in point: BiDil. “The Food and Drug Administration (FDA) approved BiDil, a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine,? heralded the 2005 press release from the FDA. However, according to a 2006 New York Times article announcing the resignation of two top executives who brought the drug to the market, BiDil’s approval “came amid criticism that the government was embracing the idea that blacks were somehow biologically different from others, which some said could promote racial stereotyping.?

Dr. Carmen Paniagua-Ramirez, of the University of Arkansas for Medical Sciences, spoke briefly about BiDil in a lecture at the Public Health Genomics course at the University of Minnesota in June 2007 (see pod cast for June 5). One of her deepest concerns about BiDil is that the FDA accepted the use of race as a biomarker. “It is not about race,? she said, “it is about a genetic variant.?

The Wall Street Journal reported in a July 2007 news item about BiDil, “The drug has been selling poorly — in part because insurers have pushed for use of the cheaper generic drugs rather than the more expensive combination pill.? Will the next mass-market pharmacogenomic offering be different? Stay tuned…

Posted by Kristin Oehlke on July 9, 2007 5:20 PM |