Robert William West, Jr. - Comment

Document ID: FDA-2010-N-0274-0008
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: July 16 2010, at 12:00 AM Eastern Daylight Time
Date Posted: July 20 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: June 17 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: August 15 2010, at 11:59 PM Eastern Standard Time
Tracking Number: 80b1b5ef
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I am a SUNY Upstate Medical University faculty member bringing Personalized Medicine to Health Care in general, and to Medical Students in particular. I have been teaching at this respective Medical School for the past 26 years. Starting in October of 2009, I began teaching a medical elective to first-, second-, and fourth-year medical students called "Personalized Medicine 101: Digitizing Diagnosis for Doctors" (given annually). The goal of this course is to translate information made at the bench to the bedside of patients. Genomic medicine is a revolutionary adjustment for the medical establishment, and the sooner budding physicians become knowledgeable in this area the better. My elective has been mentioned in Pharmacogenomics Reporter (June 09, 2010), and will be covered again in an upcoming Genome Technology story. I have made my opinions known online at two premier blogs directly related to this topic, Genetic Future (@dgmacarthur) and Genomics Law Report (@genomicslawyer), but will summarize my beliefs again here. I am VERY MUCH IN FAVOR of DTC genetic testing, and would like to be sure that our government does not over-regulate, thereby 1) stifling innovation and 2) behaving unduly paternalistically with respect to its citizens. As a molecular biologist by training, I fully appreciate the value added by genetic analysis to human health and disease. I believe, as do many others, that "I own my DNA". I instruct medical students in ELSI related to this overall issue, so I am fully aware of the complexities involved. That does not diminish my deeply held belief that genetic testing should be freely available to all, with the fewest amount of restrictions on its availability and use as possible. PLEASE, PLEASE, PLEASE do not over-regulate genetic testing and personalized medicine. Sincerely, Robert W. West, Jr. Ph.D., Department of Biochemistry & Molecular Biology, SUNY Upstate Medical University. westr@upstate.edu; http://bit.ly/bRVDBf; Twitter:westr

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