Great progress has been made in linking disease to mutations in certain genes. So why the sudden brouhaha at the FDA about companies selling gene-testing kits directly to consumers?
James Evans, a professor of genetics and medicine at the University of North Carolina explains: "[T]he ability to accurately predict disease risk from most gene tests is still in its infancy....We have no idea and neither does anybody at those companies about how to interpret those risks.”
Unfortunately, this didn't stop some companies from marketing test kits and then having representatives tell customers their risk of developing certain diseases.
According to an article in Bloomberg, "[F]our gene-testing companies are misleading U.S. consumers by providing unclear or conflicting information on the risk of disease..."
Gregory Kutz led a probe for the Government Accountability Office using undercover agents who acted as consumers. Recorded telephone conversations document:
- a customer being told her test results indicate she is "in the high risk of pretty much getting the disease.” [This implies a predictive value to her test that is unsubstantiated by scientific evidence.]
- a customer being told she could obtain DNA surreptitiously from her fiancee for testing. [This is illegal in most states.]
- Kutz being told his risk for developing prostate cancer was average, below average and above average, depending on the company.
Comments