The hits keep coming for Elizabeth Holmes and Theranos. Celebrated as the next Steve Jobs, the company and its founder have come under fire from the Wall Street Journal, the FDA has issues with their process and now its partner Walgreens seems concerned about their future together.
As Med Career News covered earlier, Holmes’ company become the darling of Silicon Valley based on her claims that her company was able to run hundreds of blood tests from one drop of blood. On the basis of those claims she became the first sole female founder-CEO of a multi-billion technology company. However, Holmes has always been secretive about the process, preferring to talk more about the implications of the technology than the technology itself.
Investigation into Medical Claims
In mid October the Wall Street Journal ran a lengthy expose which accuses the company of exaggerating the precision of some of its diagnostic tests, and using machines bought from other companies rather than its own technology for a large number of tests. The article, by investigative reporter John Carreyrou, cites several former Theranos employees who claim that while Theranos offers more than 200 types of diagnostic tests, it only ran 15 of those tests on its own machine, called Edison, as of late last year, outsourcing the rest to machines developed by other labs. (Theranos disputed that figure, but wouldn’t give the Journal a more recent one.)
The article also claims that former Theranos employees doubted the Edison’s accuracy, and raised concerns about a test last year that showed discrepancies with another company’s machine, “In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces”, according to internal emails reviewed by the Journal. “One was tested with Edison machines and the other with instruments from other companies. The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer.” The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.
According to one former employee who spoke to the Journal, one Theranos test gave potassium results so high “that patients would have to be dead for the results to be correct.”
FDA Approval Concerns
While Holmes has responded to the Journal’s accusations at length, more problems have arisen. The FDA has released documents related to their visit to Theranos’ labs that took place between August 25 and September 16, and while they are heavily redacted, they don’t look good.
The reports are Form 483s, which are issued at the end of inspections when investigators see anything that may violate the Food Drug and Cosmetics Act and contained 5 observations of note. The most troubling concern were FDA claims the containers Theranos has been using to collect blood, known as nanotainers, never got regulatory approval: “You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania.”
Around the same time as the FDA reports were released, Holmes made an appearance at the WSJD Live global technology conference in Laguna Beach, Calif and stated that the Silicon Valley laboratory company is in a “pause period” as it seeks to get its proprietary technology approved by the FDA. “We have to move, as a company, from the lab framework and quality systems to the FDA framework and quality systems,” said Holmes. At the conference, she confirmed that the company is down to offering just one test using a few drops of blood and is performing the other more than 240 blood tests it offers consumers by using larger blood samples drawn with needles from patients’ arms.
Walgreen questioning future partnership
As troubles pile up as Walgreens has announced that its future partnership with Theranos is now up for discussion. Currently Theranos operate wellness centers in 41 of more than 8,000 Walgreens. In a statement to Engadget, it said that now that it has completed the Phoenix rollout of Theranos Wellness Centers, it will now enter into talks with Theranos: “Plans to open more Theranos Wellness Centers are dependent upon both companies’ ability to reach a mutually beneficial arrangement.”
More breaking medical news on the horizon?
And perhaps the strangest allegations against Theranos, the Verge has reported that while multiple news outlets have reported that Theranos earns a portion its income from large pharmaceutical companies Pfizer and GlaxoSmithKline, who reportedly use Theranos’ tech to conduct clinical trials, representatives from both companies who spoke to the Financial Times have stated that the information is factually incorrect.
“I cannot find any evidence that we’ve done business with them in recent years,” a spokesperson for GSK told the Financial Times. When The Verge asked GSK about this, Mary Anne Rhyne, a spokeswoman for GSK told us that “GSK has not done any business with Theranos in the past two years.” When we asked if the company had worked with Theranos before then, she told us that she didn’t “have more information to share.” A Theranos spokesperson told us that Theranos had engaged in clinical trial testing for GSK starting in 2008, however, but that was before Theranos opened its retail business.
Pfizer, on the other hand, told the Financial Times that the company’s dealings with Theranos were limited. “We’ve done only very limited historical exploratory work with Theranos through a few pilot projects,” the Pfizer representative said, “and we do not have any current or active projects with them.”
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