The outfit which borught the psychological genius Wilhelm Reich to an early grave, is now gunning for the estranged wife of Google boss Sergey Brin.
According to Bloomberg, the Food and Drug Administration, which shut down Reich just in case he put big pharm out of business by coming up with a cure for cancer, has ordered 23andMe, the Google-backed DNA analysis company co-founded by Anne Wojcicki to stop selling its products.
Wojcicki was given the company which makes a Saliva Collection Kit and Personal Genome Service, which tells users whether they carry a disease, are at risk of a disease and would respond to a drug.
Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the company.
The Food and Drug Administration has to decide if the product will cause any harm to patents, or Big Pharm generally. After all if people know what is making them sick, Big Pharm can not make a lot of money a range of expensive quack cures.
Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin, started 23andMe about six years ago to help people assess their risk of cancer, heart disease and other medical conditions. Brin used the saliva kit and discovered that he had a gene that makes him susceptible to Parkinson’s.
However, the FDA is concerned about the public health consequences of inaccurate results from the PGS device. It just wants to make sure that the tests work.
“Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” the FDA wrote.
It was concerned that 23andMe plans to expand the device’s use without obtaining FDA approval.
A spokeswoman for 23andMe, Catherine Afarian, said in an e-mail that the company’s relationship with the FDA is extremely important and it will attempt to address its concerns.
In this case, the sticking point appears to be UnitedHealth Group, the largest publicly traded U.S. health insurer, which raised concern in a March 2012 report about the accuracy and affordability of the tests.
It thinks that while 23andMe might be on the right path to provide such types of genetic tests within the next 10 years there was a need to identify which work best.