Theranos is a new start-up laboratory company that got $750 million dollars of venture capital for its technology but the methodology has never been proven and has now been ordered by the FDA to submit standard testing results to prove its claims and the accuracy of its methods. Personally, I will only use the most accurate and credible labs for testing for my patients because my patient’s lives depend on it. As a Doctor of Naturopathic Medicine, getting accurate, reproducible results that enables me to accurately diagnose my patient’s problems and help them get well faster and reach their optimal level of health is my primary goal.
Recently, the Food and Drug Administration released reports based on inspections of Theranos facilities this past summer. It concluded that the company’s miniature blood containers — called “nanotainers” — were “unapproved” medical devices, which were not approved for testing anything but herpes. Amid the controversy, Walgreens said it would not open new Theranos blood testing centers while it sought answers about the company’s technology.
Now, the FDA is requiring that Theranos’ equipment and individual tests go through the regulatory process and get approval. (This will undoubtedly make the cost of their tests rise to be more in line with all the other major labs in the nation.) While Theranos says it has conducted millions of tests, mostly on the millions of unsuspecting people who found them through massive advertising campaigns and through a partnership with Walgreens, no one from outside Theranos has ever verified the technology.
As a Naturopathic Medical Doctor, in private practice for 30 years, I am not a salesman for any lab, but I do have a bias for scientific facts, truth and accuracy. I certainly never pressure any patient into doing any of the tests or procedures that I recommend, but I recommend them to find the scientific facts and truth about the cause of their illness. I need accurate reproducible results so that I can repeat those same tests to see if my treatments are working and to make sure that I have prescribed the optimum dose for each patient. I know that the cost of lab testing is significant, therefore I work hard to find the best labs and negotiate the best prices that I can for my patients. Theranos is cheap, but unfortunately not credible, so you get what you pay for and worse than wasting your money, inaccurate lab tests can cost you your health if relied upon in making a prescription.
It has now been 6 months since the Wall Street Journal’s John Carreyrou broke the news that all is not well at Theranos, the $9 billion Silicon Valley startup Laboratory company founded by Stanford dropout Elizabeth Holmes at age 19. At the outset she looked like a genius and she sold her idea to some big investors, but now it looks like her big ideas were merely ideas without any basis in reality.
Earlier this week, the Wall Street Journal revealed the latest in a long string of blockbuster revelations, that federal regulators are close to revoking the license of the company’s California lab and banning Holmes and Theranos president Sunny Balwani from running or owning any lab for two years.
The data is pretty damning. The company’s supposedly breakthrough technology replacing test tubes of blood drawn from a vein with a few drops from a finger stick simply doesn’t work. Sadly, the failure likely lead to the suicide of the company’s chief scientist, whose wife told the Journal that her husband, who coauthored 23 patents during eight years with the company, repeatedly told her before he committed suicide that, “nothing was working.”
Now that the truth of the matter has come to light, Safeway is abandoning plans to open Theranos wellness centers in 800 supermarkets, even after spending $350 million on the initiative and Walgreen’s halts expansion of their relationship and is desperately searching for a way to distance itself from the growing scandal.
When the Centers for Medicare and Medicaid Services (CMS) investigated and found “serious deficiencies” that post “immediate jeopardy to patient health and safety” at the Theranos California Lab, the company brushed it off as minor issues, but then researchers at Mount Sinai showed that the Theranos cholesterol test results are way off and the Centers for Medicare Services wrote a scathing 121-page CMS report revealing that Theranos’ proprietary Edison tester yields unacceptably inaccurate and erratic results on a whole bunch of blood tests.
“After a dozen years of development, hiring more than a thousand employees, and burning through ungodly amounts of cash, Holmes’ plan was apparently to make an enormous splash, go live on real people, and hope nobody notices that the stuff doesn’t work. At least that’s how it seems to me,”
– Steve Tobask, FOX Business News
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