Ken and the Senate

"GINA is a laudable gain, but it is only half of the regulatory reform needed. We need to turn to genetic testing itself, which, surprisingly, has escaped comprehensive federal oversight. One of the cited needs for GINA has been the explosion of genetic testing by direct-to-consumer for-profit companies. Just last month, one testing company set up a storefront in New York to hawk its wares. Many physicians and genetic counselors feel that such direct-to-consumer marketing of genomic research information is premature at best, and dangerous at worst."

"In response to a recommendation from an advisory panel to the secretary of Health and Human Services, the Food and Drug Administration, the Federal Trade Commission and the Centers for Disease Control and Prevention issued a joint warning to consumers about at-home genetic tests. But that is not enough. The FDA and FTC should directly safeguard the scientific accuracy and safety of products marketed as predictive genomic tests."

"Absent such federal protections, all states should act. Currently, 24 states prohibit or limit direct-access testing without a medical professional's involvement. In New York, the Department of Health recently sent letters warning of fines and jail time to several online gene-testing firms that offer direct-to-consumer genomic testing through laboratories not licensed to provide testing to New York residents. Other states should do the same."

"When the validity, utility and safety of breast cancer genetic testing was debated a decade ago,we proceeded cautiously. We offered testing to our patients as part of research studies. But in the new era of "home-brewed" genomic tests of unproven validity, federal regulation is needed."

"Without regulation, the commercial marketing of inaccurate or medically irrelevant genomic self-testing may do much more damage than the specter of genetic discrimination that led to GINA."

-Kenneth Offit to the Washington Post
Kenneth Offit is chief of the clinical genetics service in the Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York.

The Sherpa Says: Me thinks further regulation is coming........very soon.