According to the FDA, which sent a letter to Ann Wojcicki, CEO of the personal genomics and biotechnology company 23andMe, “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.” As a result of such precautionary bullshit, again according to the FDA, “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
I’d like to speak on behalf of every customer and future customer of 23andMe’s very important services, alongside every scientist and citizen who supports the democratization and decentralization of current and future technology, aiding in the technological advancements and progress we’re witnessing today, and just say: The FDA can go fuck themselves!
I will not stand by and allow the very same corrupt organization that halted GM salmon for 18 years(!) to do the same for this incredibly important company, which represents the medical and technological revolution we’re leading in the 21st century!
As a result of such clear injustice, an online petition has been started and will be sent to the White House, demanding that they halt the FDA’s attack on 23andMe. Over a thousand thus far (10:35 PM EST) have signed the petition, but is needing over 90,000 more. This shouldn’t be a problem given 23andMe’s global popularity and support. So I’m re-printing the petition below with a link to its original publication for you to sign:
WE PETITION THE OBAMA ADMINISTRATION TO:
overrule the FDA’s decision to bar 23andMe from selling their potentially life-saving diagnostic kits.
We, the healthcare consumers of America, demand that we maintain access to genomics testing services like 23andMe’s, which serve as a 100% privately purchased complement to government-regulated healthcare.
The FDA grossly overstates the risks associated with 23andMe’s assessments. Statements such as those suggesting that dangers like false positives may “lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions” are outrageous and patently false.
Risks associated with services like 23andMe’s are understood by private consumers, while the benefits of these services (such as early diagnoses for chronic diseases) are significant. The price of over-regulation is lengthy delays in potentially life-saving medical innovations.