The Wall Street Journal, reports that, “Amid studies showing the anti-clotting drug Plavix may not be effective for 30% of cardiac patients, federal regulators are considering updating the drug's label to include data on genetic factors that could interfere with the medicine.”
(Nearly 25 million prescriptions were written in the U.S. in 2007.)
“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. 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.”
“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts. Nobody said personalized medicine was going to be easy.
Three studies last week -- 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% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."
That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition. And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health. Larry 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 dearth of 21st regulatory tools to explore it.
These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
Indeed, not “safety” per se, but “safe use.”
According to Dr. 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. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.
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.
Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."
Dr. Grubel’s 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, not for statins.
The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”
First of all, news articles shouldn't opine. Secondly, 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%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and 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.
(Nearly 25 million prescriptions were written in the U.S. in 2007.)
“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. 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.”
“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts. Nobody said personalized medicine was going to be easy.
Three studies last week -- 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% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."
That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition. And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health. Larry 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 dearth of 21st regulatory tools to explore it.
These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
Indeed, not “safety” per se, but “safe use.”
According to Dr. 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. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.
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.
Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."
Dr. Grubel’s 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, not for statins.
The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”
First of all, news articles shouldn't opine. Secondly, 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%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and 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.
