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.
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