After months of negotiations, FDA finally lost patience and sends a warning letter to Google-backed 23andme, a genome testing company. 23andme was marketing its saliva based genetic test device and the test (Personal Genome Service) itself without an obligatory marketing clearance.
What FDA’s letter means
The letter is very direct and harsh and its tone, reminding Mrs. Anne Wojcicki, the founder of 23andme, that FDA really tried to help:
More than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies
The letter is the final warning. If 23andme fails to cease its marketing activities and provide a plan to align itself to the regulatory demands, FDA will start a regulatory action without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties – FDA warns.
At K-Message, we usually praise innovation, courage and development of new ways of dealing with complicated problems. 23andme could be a hero of our story. But Mrs Anne Wojcicki‘s approach is hard to support.
FDA’s main concern is, as specified in the letter, a potential risk of negative impact of the often alarming test results coming from PGS. False positive or false negative from the PGS may affect actions of the people. Someone who was falsely informed that has high risk of breast cancer (BRCA mutation), can undergo prophylactic surgery, chemoprevention, invasive screenings and last, but not least will suffer tremendous psychological stress.
On the other hand, false negative may lead people from the risk groups to ignore prevention at all. Another dangerous part of 23andme service is informing about personal reaction to the drug. It produces a risk of “self-managing” therapy and lowering adherence to the therapy prescribed by real HCP. Such non-compliance may lead to serious risk of illness, injury and even death, as in the FDAs example of wayfarin, popular anticoagulant or “blood thinner“, which may cause internal bleeding if overdosed.
Problems with 23andme technology
23andme technology is far from being bulletproof. The assumptions it bases on, the links between particular genes and diseases are not really mapped and confirmed in regular clinical trials on big samples. Even Mrs. Wojcicki admits, that her goal is to gather a test sample big enough to falsify the assumptions on which results are presented to the patients.
But it is not only about state-of-knowledge about human genome as today. Even the software that generates PGS results can mislead patients, as described in this personal story “My deadly disease was just a bug”. It also happened, that 23andme simply mixed the samples and 96 of its users recveived data od someone else, who just had a bad luck to have his/hers saliva on the same testing plate.
It does not make Mrs. Wojcicki any more apologetic though.
Right to know, but what?
The problem is, Mrs. Wojcicki often diminishes such concerns. She said once, that the main concern of doctors is that her service generates “non-billable, educated questions“. When the Agency first warned 23andme together with other gene testing companies in 2010, Mrs. Wojcicki’s line of defense was freedom to know information about your own body.
FDA has nothing against testing itself and having this knowledge available. The problem is that the knowledge has to be true and not misleading. As Mrs. Elizabeth A. Mansfield, director of personalized medicine in the F.D.A.’s medical device division, said to NYT, the agency agreed that people had a right to their genetic information.
The concern, she said, was that 23andMe was also providing interpretations of what that data meant medically. Some commentators, that come more from a tech than pharma tend to see the conflict between 23andme and FDA as “new vs old” clash.
We believe it is not the case this time. It is rather good ol’ regulatory action against dangerous false claim in healthcare, or even quackery. 23andme does not offer substantial evidence to support the reports provided to their clients. Their often misleading information can lead to health risk, and therefore FDA has to intervene. It has nothing to do with freedom of the information, as the information is too often false and affects really important matter.