Howard C Wetsman - Comment

Document ID: FDA-2011-N-0066-0002
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 14 2011, at 12:00 AM Eastern Standard Time
Date Posted: February 18 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: February 7 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: March 1 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80bee7f6
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Thank you for the opportunity to comment on DTC genetic testing. I am quite concerned that the great benefit of such testing will be limited and chilled by further regulation and am writing today to urge you to leave things as they are. As background let me say that I have been treating the illness of addiction for over 20 years and while there have been great discoveries during that time, there has been little change in addiction treatment. We have found the testing from DTC companies to be so great that we have funded the test for each of our last 160 patients. Those who wish share their results with me and we have been able to make some real improvement in their care as a result. Let me give you just one example of many I could give. There is an enzyme, MTHFR, that converts folate into L-methylfolate, the only form of folate the body can use. It is an important step in the production of dopamine, the main neurotransmitter of the brain's reward system. There are two known mutations of MTHFR that effect health and these can be ordered by a physician at a cost of approximately $125. With the DTC data we were able to test, not for 2 SNPs in this enzyme, but for almost 50. We were able to find an unreported SNP that helps us predict who will and who won't need supplementation with L-methylfolate. I have seen patients with life long anxiety and depression symptoms feel normal within days because of the addition of L-methylfolate. The value of this testing even at $500, which is twice the current cost, was much greater than that available through prescription channels. I felt and still do feel so strongly about it that I have funded the test for all of the patients who want it because I cannot imagine practicing good medicine without it. Please do not hinder the individual American's right to get, directly, without prescription, his own genetic information so that he can share it with the health practitioner of his choice.

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