From Social Matter Desperately Seeking Susan Jobs
My opinion is somewhat different. Keep in mind, the women SJWs tend to promote have zero redeeming qualities – think Sandra Fluke, Sandra Bland, Mattress Girl. Elizabeth Holmes, along with her accomplices, created this company that seems successful (it’s herpes simplex 1 virus test received FDA clearance), even though there is some warranted skepticism. Part of the skepticism arises from confusion about Theranos’ business model, which is not as much at the mercy of the FDA as some may assume, due to a loophole that allows Theranos to bypass the FDA:
In a profile in the New Yorker last December, Theranos revealed its plans to seek regulatory clearance, despite the fact that currently diagnostic labs are under no obligation to do so. This is something of a regulatory loophole; most diagnostic labs buy their equipment from companies like Siemens or Roche, and those vendors do need to get clearance to sell their devices. But Theranos manufactures its technology and uses it in-house, so it doesn’t actually require clearance. The FDA is considering a change to these rules, and even though Theranos has benefitted from the loophole so far, Holmes submitted a comment to the FDA encouraging them to require all testing labs to submit to review.
Class I medical-exempt devices, such as the blood tests developed by Theranos, may exempt from the FDA because Theranos uses their own labs to test the samples – as opposed to selling testing equipment. Theranos’ blood tests may have been marketed as ‘class 2′ devices (which when sold require FDA approval), which is why the FDA got involved, but that doesn’t prove the blood tests don’t work or that Theranos won’t eventually get clearance to market these as ‘class 2′ devices. In July, 2015, Theranos’ herpes blood test received FDA clearance, so that bodes well for future tests.
At the very worst, the blood tests don’t work as well as originally hoped, investors loose faith, and the company is liquidated at a large loss.
There is still a lot we don’t know, and it’s too soon to call Theranos a failure. The loss of the Safeway partnership and halting of the Walgreens partnership is a setback but not a mortal blow. My prediction is they will get through this.
The author of the hit piece, JAMES B. STEWART, omits the fact that Theranos is actually sending documents to the FDA. Theranos isn’t trying to evade peer review. Theranos plans to get FDA approval for up to 120 tests, even though such approval may not be necessary due to the loophole. From Forbes:
When critics say that Theranos should publish more data, Holmes responds that she is doing something better: getting approval from the Food and Drug Administration for 120 different Theranos tests. This is not standard practice in the industry.
Many blood tests are actually not FDA approved, because tests that are developed by the lab that uses them have been exempt from many regulations. Holmes argues that FDA approval is a much higher hurdle than simply publishing in a medical journal. It’s great that Theranos is doing this.
But the FDA has just made public its decision letter to Theranos and a far more detailed memo around the agency’s thinking. The 29-page memo doesn’t explain how the Theranos system works, but does compare samples on the existing technology and using Theranos’ new technology. Not only are the test results substantially the same, but Theranos’ device is able to replace a blood draw with just a drop of blood, as advertised.
Whether it’s Tesla, Uber, Theranos, or or any other successful start-up, the left are like bloodhounds drawn to the scent of failure of the successful, even when such failure does not actually exist. The liberal media is so desperate for the successful to fail that they have to make stuff up, turning molehills into mountains.