A Wrench in the Race for Genetic Discoveries
By Dana
The race for discovery and innovation within the field of genomics has followed an exciting and prosperous trajectory of late, and that uphill climb has spiked over the first half of 2008 for companies with a stake in the burgeoning genetic testing industry. Although genetic testing and sequencing has captivated the public for the better part of this century, the field remains largely uncharted, with much research, definition and regulation left to be put in place.
It is the absence of regulation and common definition that has brought the race to a screeching halt for genetic testing companies that specialize in Direct-to-Consumer (DTC) genetic testing. These tests, purported by companies like 23andMe, Navigenics, and deCODE Genetics to help consumers determine whether they are carrying genes associated with everything from baldness to breast cancer, have spawned major debate and a public outcry for a crackdown on what some regulators suggest is a rampant disregard of social responsibility. Most recently, the California Department of Public Health issued cease-and-desist letters to 13 companies accused of peddling DTC genetic tests to state residents, an action strikingly similar to that taken by New York against 31 genetic testing companies earlier this year.
In today’s New York Times, Andrew Pollack explores some of the more extreme points-of-view to emerge from this issue. On one side is a group beseeching federal measures be put in place to ensure companies offering DTC tests are licensed and provide results with “clinical” validity—that is to say, the assurance that a recognized genetic variation is an actual indicator of a disease or an increased risk for one. Following this chain of logic, it is assumed these federal measures will help prevent the unfounded hysteria that can crop up after an individual receives an “invalid” genetic reading. On the other side are individuals who staunchly believe every consumer has the right to have and control his or her complete, accurate and affordable medical information and subsequent treatment, genome sequence and all. Stifling the power of DTC companies to innovate and offer services, they say, will stifle the fundamental right of individuals to take control of their own lives and their own health care.
It’s a valid debate, and one that will be interesting to watch as the arguments continue to refine and take shape. Eliminating consumer access to genetic testing services might prevent patients from unecessarily going off the deep end in the wake of receiving an ominous genetic reading. At the end of the day though, the same patients who take advantage of these services will surely go to any measure to self-diagnose–and go off the deep end anyway after they draw their own ominous conclusions from information they’ve gleaned from the Internet, medical journals and conversations with friends. If we run block on companies that are helping to drive important science and research, wouldn’t we have to likewise regulate everything that could potentially be misused or misinterpreted? Where does it end, and how far will these naysayers push before this revolutionary science is reduced to a sliver of its true potential?
Add comment June 26th, 2008
