Unfortunately the FDA has taken another step in the wrong direction. Recently it ordered the private company 23andMe to stop selling its at-home genetic testing kit. Originally used primarily for ancestry related information, the 23andMe data, which is based on the user’s raw genomic data obtained from a saliva sample, also includes information such as the tendency for hereditary disease risk.
In a letter to Anne Wojcicki, 23andMe CEO, the FDA claims the marketing of the 23andMe Saliva Collection Kit and Personal Genome Service is currently in violation of the Federal Food, Drug and Cosmetic Act. According to the agency, the kit falls under the heading of a regulated medical device under section 201(h) of the FD&C Act, as it is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”
In this knee jerk reaction the FDA ruling makes the assumption that “We the People” are not responsible enough or smart enough to own or understand our own genetic information. Most individuals, at least those I have talked to, who are privy to their genetic information, courtesy of 23andMe, understand that the information provides tendencies or traits but not necessarily actualities. It can however give indicators that can lead doctors to pursue more accurate testing. 23andMe data is nothing more than a puzzle piece in a larger picture.
However if one looks a little deeper, a darker motive is implied. It has long been known that there are certain forces in the world today that want to control genetic information. This year the Supreme Court ruled that human genes cannot be patented in response to controversial concept of private companies trying to control the human genome. Just imagine a corporation owning a section of your genetic code that resides in your body. 23andMe did just the opposite; it gave the customer unfettered access to their own genetic code.
In addition, the FDA states in their letter to 23andMe, “For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.” I personally do not know many people who would “undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions” as claimed by FDA without pursuing further testing guided by competent medical personnel.
The FDA, like they have done before, makes the assumption that the average person is a total idiot that cannot take data in stride and put it in the proper perspective. Make no bones about it, this decision is more about control, than safety.
What’s next, outlawing at home pregnancy test kits?