The Phenomena Otherwise Known as DTC Genetic Tests

February 14th, 2011
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“I looked in the Yellow Pages. ‘Furniture Movers’ we’ve got; ‘Strange Phenomenon’, there’s no listing.” – Diane in Poltergeist
I had to laugh at one of last week’s headlines on the Daily Scan from Genome Web. It was titled, “They’re Baaaaaack!” Before reading the article, I imagined it had something to do with the Poltergeist series of movies where chaos and unexplained phenomena occur – objects careening through the air along with visitations from old and terrifying ghosts.   But when I read the article, it had to do with the revisiting of the direct-to-consumer genetic (DTC) tests rather than some type of paranormal activity.  Not exactly a poltergeist but nevertheless a phenomenom that 1) won’t go away, 2) is somewhat chaotic, and 3) is worth following.
From March 8-9, 2011, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee will host a public meeting.  The group will take comments and make recommendations on DTC tests.  Several issues are on the agenda with the focus on the risk and benefits of such tests and the potential availability to consumers without a physician’s prescription.
Proponents of DTC tests believe that consumers who wish to purchase and take the tests should have easy access to information about their genetic makeup. Such access, the proponents argue, would allow consumers to make informed decisions with regard to such things as whether they are carriers of a certain genetic disease, have a predisposition to develop a particular cancer, or whether they will respond to a particular medical treatment.   In essence, information obtained from DTC tests would empower consumers to take control of their own health.
Those who are uneasy about the risks related to DTCs are concerned about test results being misinterpreted and acted upon in the absence of other important substantiating information. They argue that physicians play an important role as gatekeepers of medical information.
Developers of DTC tests are another category of influence on this issue. They play a role in helping to shape the debate around the level of scientific evidence needed to support the test claims.
In the movie Poltergeist, the character Marty explains: “Poltergeist disturbances are fairly short duration. Perhaps a couple of months. Hauntings can go on for years.”
We may not know until months after the Advisory Committee meeting whether we are dealing with a poltergeist or a haunting when it comes to the phenomena of DTC genetic tests, but we do know “they are here” and they will make an impact on the future of healthcare.

Where do you come down on this issue? Are the tests important for consumer empowerment or do physicians need to be involved via the traditional prescribing process? What role should developers play in setting standards for scientific evidence? What should be the FDA’s role in this process? Please share your thoughts with us.

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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.