GINA may encourage problematic direct-to-consumer gene tests

Public interest group welcomes Genetic Information Non-discrimination Act as good first step

(This statement can be attributed to Marcy Darnovsky, PhD, Associate Executive Director, Center for Genetics and Society.)

President Bush's signing of the Genetic Information Non-Discrimination Act (GINA) is a welcome step. Americans can now take genetic tests with less worry that employers or health insurers might use the results against them.

But while the enactment of GINA is laudable, the new law falls short of fully protecting Americans' health and well-being in the DNA age.

On the plus side, medically necessary genetic tests are now far less likely to result in discrimination. Most genetic tests administered in a medical context are clinically valid - that is, their results are meaningful - and they often suggest useful medical interventions or behavioral changes.

Unfortunately, GINA may encourage people to take "direct-to-consumer" genetic tests that are now being offered and aggressively marketed by several dozen companies. These tests are quite a different matter.

Some companies offering at-home genetic tests make claims for which there is little scientific evidence: that the tests detect genetic variations for non-medical traits such as "hair loss" and "athletic performance," or reveal the optimum diet for your genetic profile, or tell the company how to customize a "scientifically proven anti-aging crème…just for you."

Several of the companies, including 23andMe, Navigenics and DeCodeMe, offer to scan your entire genome for variants they say predispose you to a range of conditions, from Alzheimer's to arthritis to obsessive-compulsive disorder. These whole-genome tests are marketed online at costs up to several thousand dollars.

This burgeoning commercial sector is developing without federal oversight or regulation. Although three U.S. agencies issued a 2006 fact sheet warning consumers to approach at-home gene tests with "a healthy dose of skepticism," no federal agency has stepped up to ensure their accuracy, their clinical validity, the truth of marketing claims, or whether genetic privacy will be maintained.

Though GINA prohibits discrimination whether a genetic variation is detected in a medical setting or at home, it does not address any of these problems.

In addition to potential harms to individuals as patients and consumers, the direct-to-consumer tests pose social concerns, such as the use of the vast amounts of genetic information being collected by commercial enterprises. People are paying to hand over their DNA samples to companies that will likely sell it or use it to develop new products.

Another social concern is that consumer DNA tests may feed the "gene myth," the exaggerated idea about the role of genes in individual identities and in society. For example, the tests could bolster false explanations of social and health disparities as the result of biology rather than of access to housing, education and health care.

The Center for Genetics and Society is a public affairs and policy advocacy organization working to encourage responsible uses and effective societal governance of human biotechnologies.
 

Contact:
Marcy Darnovsky
510-625-0819 x305

Jesse Reynolds
510-625-0819 ext 308