by Dr. Hsien-Hsien Lei
Posted April 4, 2008 in DNA Testing
Direct-to-consumer genetic testing companies will have a lot to mull over this weekend after the publication of a Genetics and Public Policy Center case study of personalized medicine in Science. The authors examined the use of CYP450 testing in the selection and dosage of SSRI drugs for depression and come up with some general recommendations for the regulation of direct-to-consumer genetic testing.
Enhanced enforcement by the Federal Trade Commission against misleading claims. The agency has that authority, the researchers said, but it has “has not been a priority.”
Development of a mandatory registry for those offering genetic tests. They would be required to submit data supporting the intended use of the tests to a publicly accessible database.
FDA oversight of laboratory-developed tests, as opposed to those sold as a kit, which are already regulated by the agency.
- Individuals have a right to learn their genotype and control that information. If patients are denied direct access to this testing they may be reluctant to be tested because they are not confident that the confidentiality of the test results will be adequately protected.
- Excessive regulation, such as is advocated by the Genetics and Public Policy Center, will impede the already excessively slow rate of adoption of DNA testing for use in medication management. Were this testing adopted at a faster pace there are likely tens of thousands of adverse medical events that would have been prevented.
- There needs to be symmetry between the level of proof required for the adoption of a technology and the potential risk and cost benefit ratios.
- A peer developed rating system that describes where a given test lies on the continuum of scientific knowledge about the utility, acceptance and proof of that test. In this way individuals would be provided with the tools needed to help them make informed decisions.
The authors of the case study, however, point out that genetic testing may actually backfire. Instead of improving a patient’s health, it could cause damage instead.
…a patient informed of his or her CYP450 profile might independently change the dose of antidepressant medication with adverse health outcomes. …the current situation also could lead both providers and patients to lose trust in the value of genetic testing to improve drug-prescribing decisions.
Trust is the key. In an ideal world, patients would trust their physicians with all the information that’s needed to maximize health. Unfortunately (or fortunately?), humans like being autonomous and don’t want to lose control especially when it comes to their own bodies. Handing over all the decision making to their doctors is against what many patients are inclined to do. It behooves physicians to gain the trust of their patients by demonstrating a solid knowledge of genetic testing and their strengths and limitations. Even with greater federal regulation, the average family doctor is simply not qualified and may not even be any more qualified to give advice on genetic testing than the informed consumer. (I’m sure Dr. Steve Murphy would agree.)
Despite the warnings, co-author Kathy Hudson says in a Newsweek interview that there is an upside to genetic testing:
I think genetics has a huge amount to offer in making really important real-time health-care decisions. I think increasingly we’re going to see genetic testing as being really important in both prescribing decisions and in treatment decisions. For example, will you respond to chemotherapy or not? Will you keel over and die if I prescribe this antiviral versus that antiviral?
Do you think direct-to-consumer genetic testing is good or evil? Take the poll in the Eye on DNA sidebar.
NB: The Genetics and Public Policy Center previously released an American Society of Human Genetics (ASHG) Statement on Direct-to-Consumer Genetic Testing.
DNA Direct does not offer interpretation of CYP450 testing for SSRIs. DNA Direct is a web-enabled genetic consultation company staffed by board certified genetic counselors, with medical oversight provided by an M.D. medical geneticist. All medical genetic testing is provided according to standard medical guidelines developed under the oversight of our medical director. Secure, web-enabled interpretation and genetic consultation regarding test results is highly personalized to the patient. We advocate for consultation with a local provider if one is available for the patient â€“ not always possible given the shortage of genetics professionals. Our patients may seek consultation directly or a physician may refer a patient for services. Of note, our most common healthcare provider referral is for consultation regarding CYP450 testing for tamoxifen. No patient receives testing through DNA Direct without the involvement of a healthcare provider.
Let’s Talk About Direct-To-Consumer Genetic Testing...
The Next Generation’s Perception of Genetic Testing...
Preimplantation Genetic Diagnosis (PGD): A Discussion...
Drug Companies Should Offer Free DNA Tests...
Dr. Robert Marion on Direct-to-Consumer Genetic Testing...
Commercials for Myriad BRACAnalysis Genetic Test Under Scrutiny...
American Society of Human Genetics (ASHG) Statement on Direct-to-Consumer Genetic Testing...
Sorry, the comment form is closed at this time.
Search Eye on DNA
- Genetic Genealogy on Faces of America
- DNA Network Tweet Cloud
- Genetics = Real Science
- Larry David’s DNA Test
- Lopez Tonight First Late-Night Show to Offer DNA Testing
- American Genes Don’t Exist
- Knowledge about Genetic Risk is Power or is it Fear?
- Murderer Gets Reduced Sentence Because His Genes Made Him Do It
- Video: Knome’s Ari Kiirikki Speaks with Medgadget
- DNA Toys: Ben 10 and Digimon Digivice
- 100 Facts About DNA
- Salaries for Jobs in Genetics
- Fetal Gender DNA Tests Answer Common Pregnancy Question...Or Not
- How To Determine Paternity Without A DNA Test
- What does DNA mean to you?
- Eye on DNA Interview: Dr. Tzung-Fu Hsieh of RedTracer DNA Test for the Red Hair Gene, MC1R
- Books About DNA: The Crime of Reason by Robert B. Laughlin
- Genetically Modified Organisms Bring in the Cash
- Navigenics Introduces Physician Portal and Annual Insight Service
- People Who’ve Had Their Genomes Sequenced
09/29/2009 07:03 am
- Larry David’s DNA Test
11/17/2009 02:52 am
- 23andMe DNA Tests for $399, Down From $999
09/10/2008 04:33 am
- Crazy Genetic Marketing Ideas
07/05/2008 09:14 pm
- Parenting Children Using Genetic Tests
05/18/2009 02:09 am
- Business of DNA
- DNA @ Google Answers
- DNA and Disease
- DNA and Genealogy
- DNA and the Law
- DNA Around the World
- DNA Fun
- DNA in General
- DNA Inventions and Gadgets
- DNA Lab Talk
- DNA Podcasts and Videos
- DNA Quotes and Excerpts
- DNA Testing
- Gene Therapy
- Genetic Engineering
- Genetically Modified Foods and Organisms
- Jobs Involving DNA
- Personalities with DNA
- Polls About DNA
- January 2010
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009
- March 2009
- February 2009
- January 2009
- December 2008
- November 2008
- October 2008
- September 2008
- August 2008
- July 2008
- June 2008
- May 2008
- April 2008
- March 2008
- February 2008
- January 2008
- December 2007
- November 2007
- October 2007
- September 2007
- August 2007
- July 2007
- June 2007
- May 2007
- April 2007
- MRSA Notes
- Christina Loves
- The Personal Genome
- Effect Measure
- Another Blasted Weblog
- A Blog Around The Clock
- Dream Mom