Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?
Posted Jan 07 2009 5:10pm
Will Plavix be the next drug up for a genetic test? There are not many alternative drugs either that could easily replace the functionality of Plavix, it is a blood thinner. One idea would be to monitor patients with poor liver or kidney metabolization. as suggested here, a blog written by Steve Murphy, MD of New York who has a personalized medicine practice, and thus electronic records would help the cause here tremendously as manually if a practice has a substantial amount of patients, it would be a nightmare. At this point, the FDA does not have an idea as to what exactly the label should say!
Popular heartburn medications interfere with Plavix as well. There is already a test for another blood thinning medication, Warfarin available, so perhaps Plavix will be next on the list, however, with Warfarin we still don’t know if Medicare will pay for the test as of yet. Dr. Milos from Helicos and I had touched on that subject a few months ago during my interview relative to the progress being made with genomics and personalized medicine.
“The Sherpa Says: I see that lawsuit creeping closer and closer......We need some educators and damn fast! The durg-drug interaction with PPIs has been a possibility for years, the gene-drug interaction too....now what about the gene-drug-drug????”
Dr. Murphy states we need more education with physicians on personalized medicine, and here’s a link below that might help the cause along with information from a prior post. This is one more example of information overload – complicated and complex information needed to make an intelligent decision which will require teamwork and some good information intelligence and filtering. BD
American College of Preventive Medicine (ACPM) and Navigenics, Inc. today announced a medical education program designed to improve physicians' understanding of genetic risk factors for disease, the current evidence about the use of genomic toolsand technologies to determine risk, and promising practices for utilizing those tools to aid in disease prevention.
Through an unrestricted educational grant from Navigenics, ACPM is independently developing this continuing medical education (CME) course, titled Genetic Risk, Screening and Intervention, to address the growing use of genetic testing services and to examine their evidence-based impact on the practice of medicine.
The Genetic Counseling Foundation has been established that could offer both physicians and patients a bit more background and how the process is progressing and where genetic testing could be applicable as well and help with some of the confusion here. In the family practice office, there is not a lot of time for research and study with the heavy flow patients a normal physicians sees in a day.
Food and Drug Administration officials, however, said they aren't sure what changes to make to the label and what to tell cardiologists to do because of a variety of complications. To start, three studies published last week in prominent medical journals came to different conclusions about how many patients are at high risk for heart attack or stroke despite regular use of Plavix.
The complications with 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, three new studies have pinpointed a likely genetic factor inhibiting the drug's efficacy - but that has opened up more questions than the FDA, physicians, patients, insurance companies and the firm that sells Plavix can answer.
Doctors say the Plavix situation highlights the need for individually tailored medicine." Clearly I think just the blind administration of these drugs is rapidly coming to an end," said Paul Gurbel of Baltimore's Sinai Hospital. Dr. Gurbel authored one of the first studies showing that many heart patients do not process Plavix effectively.
Doubling the dose of Plavix may make it more effective in patients who have the gene mutation, said Dr. Robert Epstein - author of the Medco study. He has been studying the impact of higher dosages and noted that such an increase may also increase internal bleeding.