Comments on: Direct-To-Consumer Genetic Tests - Good or Evil? http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/ How will it change your life? Fri, 29 Aug 2008 13:07:12 +0000 http://wordpress.org/?v=2.5.1 By: Stacey Sigmon http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56430 Stacey Sigmon Tue, 22 Apr 2008 18:51:54 +0000 http://www.eyeondna.com/?p=1111#comment-56430 LMY - I agree with what you mention about the need for regulations and enforcement via our medical/scientific community. I support that idea that we all want a little privacy, especially when it comes to medical matters, but the the fact that even professionals in this field make mistakes further supports the argument that DTC companies and their consumers need not approach these issues with such a relaxed viewpoint (especially with regards clinical and analytical validity). LMY -
I agree with what you mention about the need for regulations and enforcement via our medical/scientific community. I support that idea that we all want a little privacy, especially when it comes to medical matters, but the the fact that even professionals in this field make mistakes further supports the argument that DTC companies and their consumers need not approach these issues with such a relaxed viewpoint (especially with regards clinical and analytical validity).

]]> By: LMY http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56428 LMY Tue, 22 Apr 2008 14:32:10 +0000 http://www.eyeondna.com/?p=1111#comment-56428 I agree with the main problem between conflicting parties of interest, the public policy advocating against DTC verse providers, is the lack of communication in advertisements and scientific understanding of the products by consumers and health professionals. It is a horrible idea to ban DTC, due to its already known medical successes and potential for scientific advancement, but is an equally awful idea to remove all regulation. It is imperative for the FDA to implement and enforce effective regulation of prescription and treatment of DTC through medical professionals proficiently educated in this technology. Negative health consequences of DTC occur when consumers use their own instinct on using a DTC genetic test or product. FDA needs to ensure DTC providers primary goalis the safety of their consumer. Additionally, DTC advertising needs to be monitored and approved by FDA in order to prevent consumers from being wrongly influenced by misleading commercialization. I agree with the main problem between conflicting parties of interest, the public policy advocating against DTC verse providers, is the lack of communication in advertisements and scientific understanding of the products by consumers and health professionals. It is a horrible idea to ban DTC, due to its already known medical successes and potential for scientific advancement, but is an equally awful idea to remove all regulation. It is imperative for the FDA to implement and enforce effective regulation of prescription and treatment of DTC through medical professionals proficiently educated in this technology. Negative health consequences of DTC occur when consumers use their own instinct on using a DTC genetic test or product. FDA needs to ensure DTC providers primary goalis the safety of their consumer. Additionally, DTC advertising needs to be monitored and approved by FDA in order to prevent consumers from being wrongly influenced by misleading commercialization.

]]> By: VT http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56417 VT Tue, 22 Apr 2008 02:23:22 +0000 http://www.eyeondna.com/?p=1111#comment-56417 DTC genetic testing will be a good thing to mankind. But consumers should chat with professional and policy groups about DTC genetic testing before going to do the testing. Because their understanding of the results received from direct-to-consumer genetic tests would enhanced the better understanding with patient's individual situation, or also they can implement advisory language for companies to use in providing test analysis directly to consumers. This would allow for continuing improvement in consumer understanding of genetics information to become a more common part of individual health and medical treatment plans DTC genetic testing will be a good thing to mankind. But consumers should chat with professional and policy groups about DTC genetic testing before going to do the testing. Because their understanding of the results received from direct-to-consumer genetic tests would enhanced the better understanding with patient’s individual situation, or also they can implement advisory language for companies to use in providing test analysis directly to consumers. This would allow for continuing improvement in consumer understanding of genetics information to become a more common part of individual health and medical treatment plans

]]> By: Michelle Mejia http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56416 Michelle Mejia Tue, 22 Apr 2008 02:03:07 +0000 http://www.eyeondna.com/?p=1111#comment-56416 As I have read more and more regarding DTC testing as well as the current regulatory climate I can't help but think we are not ready for such a powerful biomedical technology to become a commodity. If, without strong regulation, companies are forthright about the fact that their main concern is monetary and NOT necessarily validity of testing and results OR protection of the patient and/or physician input, it's safe to say that not only IS much much more federal regulatory input necessary, it is NEEDED before any further claims are made and DTC tests are advertised, produced, and/or sold. The science to support the validity of genetic markers and indicators of possible genetic pre-dispositions etc needs to come BEFORE dtc tests are marketed and SOLD to the masses at large. There most CERTAINlY needs to be physician mediated attianment an diagnostic use of the results of the tests as well. As I said before, I think this is something the world at large is simply not ready for here and now. As I have read more and more regarding DTC testing as well as the current regulatory climate I can’t help but think we are not ready for such a powerful biomedical technology to become a commodity. If, without strong regulation, companies are forthright about the fact that their main concern is monetary and NOT necessarily validity of testing and results OR protection of the patient and/or physician input, it’s safe to say that not only IS much much more federal regulatory input necessary, it is NEEDED before any further claims are made and DTC tests are advertised, produced, and/or sold. The science to support the validity of genetic markers and indicators of possible genetic pre-dispositions etc needs to come BEFORE dtc tests are marketed and SOLD to the masses at large. There most CERTAINlY needs to be physician mediated attianment an diagnostic use of the results of the tests as well. As I said before, I think this is something the world at large is simply not ready for here and now.

]]> By: CRL http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56415 CRL Mon, 21 Apr 2008 23:30:30 +0000 http://www.eyeondna.com/?p=1111#comment-56415 The more I read on the issue, the less convinced I am that I fall on one side or the other whole heartedly. I do think that these tests are capable of good when used properly and interpreted properly. I also think that the government can play an integral part in this system and help to make sure that this technology is not misused. I feel that if private companies are given complete control of this, than they will run with it and use it solely as a mean to make more money. Bob Smith seem to illustrate two very different sides of the issue and I agree with him that there has to be some middle ground found before anything is decided upon. The more I read on the issue, the less convinced I am that I fall on one side or the other whole heartedly. I do think that these tests are capable of good when used properly and interpreted properly. I also think that the government can play an integral part in this system and help to make sure that this technology is not misused. I feel that if private companies are given complete control of this, than they will run with it and use it solely as a mean to make more money. Bob Smith seem to illustrate two very different sides of the issue and I agree with him that there has to be some middle ground found before anything is decided upon.

]]> By: RAD http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56414 RAD Mon, 21 Apr 2008 22:41:06 +0000 http://www.eyeondna.com/?p=1111#comment-56414 Having a sister with autism I generally like the idea of genetic testing and that DTC genetic testing may lead to a more personalized health care but some form of regulation is needed, whether through federal or state government. My concerns are with the validity of the test results, why the test is ordered, and how correct the interpretation is. I read that in New York, DTC companies were required to get permits through the health department and that all tests had to be ordered by licensed health care professionals. I feel as though some people may get tested just because it's the "in" thing leading to false positives that have many worried. Once/If the kinks are worked out I worry that insurance companies may abuse this information. Whether this be increasing premiums or cutting coverage. Having a sister with autism I generally like the idea of genetic testing and that DTC genetic testing may lead to a more personalized health care but some form of regulation is needed, whether through federal or state government. My concerns are with the validity of the test results, why the test is ordered, and how correct the interpretation is. I read that in New York, DTC companies were required to get permits through the health department and that all tests had to be ordered by licensed health care professionals. I feel as though some people may get tested just because it’s the “in” thing leading to false positives that have many worried. Once/If the kinks are worked out I worry that insurance companies may abuse this information. Whether this be increasing premiums or cutting coverage.

]]> By: Bronwyn http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56410 Bronwyn Mon, 21 Apr 2008 19:28:49 +0000 http://www.eyeondna.com/?p=1111#comment-56410 I think we should be careful and not place all of our trust in these tests. They are good tools to have and can help people, but not everything has a genetic basis. They should be used for helping patients worried about genetic diseases that may show up later on in life, but everyone needs to keep in mind that other factors also play a significant role in our health. I think we should be careful and not place all of our trust in these tests. They are good tools to have and can help people, but not everything has a genetic basis. They should be used for helping patients worried about genetic diseases that may show up later on in life, but everyone needs to keep in mind that other factors also play a significant role in our health.

]]> By: Steven Murphy MD http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56387 Steven Murphy MD Sun, 20 Apr 2008 13:34:07 +0000 http://www.eyeondna.com/?p=1111#comment-56387 Chris, I agree with your concerns. Often Prenatal Genetic Evaluations can be difficult. Sometimes an Ob/GYN or a prenatal genetic counselor can have difficulties in presenting this information. Sometimes this is due to training issues. Such as a Genetic Counselor not being trained in medicine, or an Ob/GYN not being trained in genetics. Other times, there can be a simple difference of personalities and opinions. I apologize for the poor experience you had. Triple screen/quad screen, I feel, is a genetic test of sorts. It tests for risk of genetic anomalies. Down Syndrome is a genetic condition. I will counter that....as woefully prepared as the health community is. Most laypersons are even worse off when it comes to genetic and health literacy. So, I think we all have a lot of learning to do. Especially if we plan on buying Do It Yourself genetic testing. -Steve www.thegenesherpa.blogspot.com Chris,
I agree with your concerns. Often Prenatal Genetic Evaluations can be difficult. Sometimes an Ob/GYN or a prenatal genetic counselor can have difficulties in presenting this information. Sometimes this is due to training issues. Such as a Genetic Counselor not being trained in medicine, or an Ob/GYN not being trained in genetics. Other times, there can be a simple difference of personalities and opinions. I apologize for the poor experience you had.

Triple screen/quad screen, I feel, is a genetic test of sorts. It tests for risk of genetic anomalies. Down Syndrome is a genetic condition.

I will counter that….as woefully prepared as the health community is. Most laypersons are even worse off when it comes to genetic and health literacy. So, I think we all have a lot of learning to do. Especially if we plan on buying Do It Yourself genetic testing.

-Steve
http://www.thegenesherpa.blogspot.com

]]> By: Chris Korey http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56386 Chris Korey Sun, 20 Apr 2008 11:54:22 +0000 http://www.eyeondna.com/?p=1111#comment-56386 I have enjoyed reading all of the perspectives on DTC. One thing that seemed to come up a lot is the need to have these tests done through the medical profession in order to ensure that consumers are correctly informed of the ramifications of a particular test. My concern is one that Steve brought up in a recent post: http://thegenesherpa.blogspot.com/2008/04/why-biostatisticians-should-get-paid.html Are our medical professionals (doctors, PA, and nurses) really that much more prepared to understand these tests as compared to the general public? Certainly, they have an expertise in human biology, but I would suggest that they do not have the genetics or statistical background that will be required to deal with this information in an informed way. Most undergraduate science majors and medical curriculums are not heavy in general genetics, medical genetics, and biostats. Certainly there are Clinical Geneticists around but, as others have pointed out, not nearly enough to deal with the upcoming deluge of genetic information. My own bad experience with a positive triple screen blood test (a standard, non genetic test for neural tube defects and downs) during my wife's first pregnancy gives me little confidence that our medical professionals are trained to be the gate keepers of DTC information. I have enjoyed reading all of the perspectives on DTC. One thing that seemed to come up a lot is the need to have these tests done through the medical profession in order to ensure that consumers are correctly informed of the ramifications of a particular test. My concern is one that Steve brought up in a recent post:

http://thegenesherpa.blogspot.com/2008/04/why-biostatisticians-should-get-paid.html

Are our medical professionals (doctors, PA, and nurses) really that much more prepared to understand these tests as compared to the general public? Certainly, they have an expertise in human biology, but I would suggest that they do not have the genetics or statistical background that will be required to deal with this information in an informed way. Most undergraduate science majors and medical curriculums are not heavy in general genetics, medical genetics, and biostats. Certainly there are Clinical Geneticists around but, as others have pointed out, not nearly enough to deal with the upcoming deluge of genetic information. My own bad experience with a positive triple screen blood test (a standard, non genetic test for neural tube defects and downs) during my wife’s first pregnancy gives me little confidence that our medical professionals are trained to be the gate keepers of DTC information.

]]> By: Steven Murphy MD http://www.eyeondna.com/2008/04/04/direct-to-consumer-genetic-tests-good-or-evil/#comment-56369 Steven Murphy MD Fri, 18 Apr 2008 18:20:04 +0000 http://www.eyeondna.com/?p=1111#comment-56369 Dana, You are correct. This is precisely why we need to call our Senators and demand GINA be passed! It may not be a perfect bill, but it will be the best we have for now. -Steve www.thegenesherpa.blogspot.com Dana,
You are correct. This is precisely why we need to call our Senators and demand GINA be passed!
It may not be a perfect bill, but it will be the best we have for now.
-Steve
http://www.thegenesherpa.blogspot.com

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