Print“Personalized medicine is not about denying care. It's about providing the right care. The four rights (right medicine at the right time to the right patient in the right dose).”
Doctors wrote nearly 25 million prescriptions for the anti-clotting drug Plavix in the United States in 2007, but as The Wall Street Journal reports, with studies showing it may not be effective for 30 percent of cardiac patients, the U.S. Food and Drug Administration is considering updating the drug’s label to “include data on genetic factors that could interfere with the medicine.”
“The issues concerning Plavix show the promise and problems with the new area of ‘personalized medicine,’ where drugs are tailored to certain people based on their genetic makeup,” the Journal said. “In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy—but that finding has opened up more unanswered questions.”
Nobody said personalized medicine was going to be easy. “Unanswered questions” are a good thing. It means that we’re now being forced to think hard about how to address these new facts.
Three studies in December—two in the New England Journal of Medicine and one in The Lancet—identified a genetic abnormality in some heart patients that could interfere with their liver’s ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.
Two of the studies suggested the drug was less effective in about 30 percent of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5 percent of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA’s office of clinical pharmacology, the agency is struggling with what the label is going to say given the ambiguity of the data. “Personalized” labeling is never going to a black-and-white situation. And it’s the FDA’s job to review all of the information and then make the best choice on behalf of the public health. Lesko’s honesty acknowledges some tough truths about drug regulation—like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the related dearth of the 21st Century regulatory tools to explore it.
According to Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation. This is similar in concept to the FDA’s change to the Warfarin label—but with one big difference. At present, there aren’t any alternatives to Plavix approved for use in the United States. That raises the question what do doctors do once they find out a patient has the gene mtation.
It’s a good question—and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.
Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, told the Journal that he thinks “the blind administration of these drugs is rapidly coming to an end.” His comment is a clarion call that the era of “trial-and-error” medicine is over. One size does not fit all—not for anti-clotting drugs, not for cancer medications, and not for statins.
The Journal suggests that the Plavix studies may give a boost to personalized medicine “as a cost-saving measure under President-elect Barack Obama.” The paper notes that as an Illinois senator, he introduced a bill encouraging genomic research and personalized medicine. “Insurance companies might be able to limit prescriptions for Plavix based on patients’ genetic makeup, as they do now with some cancer drugs,” the Journal said.
Personalized medicine is not about denying care. It’s about providing the right care. The four rights (right medicine at the right time to the right patient in the right dose). And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30 percent) doesn’t mean these patients don’t need treatment—it means that they need alternate therapy, newer therapy, therapy that may cost more than Plavix—and will cost considerably more once it goes off-patent.
And as far as former Senator Obama’s “Genomics and Personalized Medicine Act” goes,I look forward to hearing about its passage during his first State of the Union address.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
January 06, 2009
http://www.burrillreport.com/article-personalized_denials.html
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