Disclosure: I had a Theranos blood test taken inside a Walgreens pharmacy this last July.
Second disclosure, I am not an attorney, and while I'm not aware of any pending litigation, it's getting harder to imagine how the growing controversy surrounding Theranos has any concrete resolution outside a court of law. The allegations against the company revolve around the accuracy of their blood tests and it now appears to be causing serious heartburn with their lead partner for retail locations ‒
According to sources inside Walgreens ‒ as cited by Wall Street Journal reporters Michael Siconolfi, John Carreyrou and Christopher Weaver late yesterday ‒ the Theranos roll out inside Walgreens is now under review and won't expand further.
Walgreens Boots Alliance Inc. won’t open any new Theranos Inc. blood-testing centers until the startup company resolves questions about its technology, according to a Walgreens official. Walgreens Scrutinizes Theranos Testing ‒ Wall Street Journal ‒ 10/23
The announcement earlier tonight comes shortly after the revelations made just eight days ago by investigative journalist John Carreyrou. In that piece ‒ Hot Startup Theranos Has Struggled With Its Blood‒Test Technology ‒ John revealed detailed findings from his months-long investigation into the company. The most serious allegation revolved around possible manipulation of proficiency tests which are used to test the accuracy of equipment used for blood tests. Theranos uses an undisclosed number of test machines and at least some of the machines were invented by the company itself (called Edison) and others were bought from large manufacturers like
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.
Beyond those specific allegations, clinical skepticism was also evident from John's investigation. Not just by the clinical community, but also from Theranos employees. Also from John's original article:
Some of the potassium results at Theranos were so high that patients would have to be dead for the results to be correct, according to one former employee.
Other doctors said they stopped steering patients to Theranos because of results they didn’t trust. “I don’t want my patients going there until more information and a better protocol are in place,” says Gary Betz, an internist in Phoenix.
In March 2014, a Theranos employee using the alias Colin Ramirez alleged to New York state’s public-health lab that the company might have manipulated the proficiency-testing process.
Fortunately for me, the test I took in July was purely for the curiosity of the experience and not for any clinical need. A series of announcements earlier this year ‒ along with a sizable footprint inside Walgreens here in Phoenix ‒ made it both convenient and very low cost. One of those announcements was by the State of Arizona (House Bill 2645) which made it legal for consumers to order blood tests without a doctor's order.
I decided to try a relatively basic, compound test and wrote about my generally favorable retail experience shortly afterward. I was also aware of the controversy ‒ mostly in the scientific community ‒ so my summary conclusion had this disclaimer:
A great consumer experience doesn’t resolve the clinical controversy surrounding the company, of course, but it absolutely does have to behave like a retail, consumer experience.
While I didn't reference it specifically, perhaps the harshest criticism appeared in JAMA this last February.
However, stealth research creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and mass media hype. The unquestionable success of computer science, engineering, and social media technologies has created reasonable hope that these technologies can also improve health in ways that the biomedical and life sciences have failed to do until now. But then how can the validity of the claims be assessed, if the evidence is not within the reach of other scientists to evaluate and scrutinize? Stealth Research - JAMA ‒ John P. A. Ioannidis, MD
While the criticism is fair, it's by no means the whole story. Neither are the allegations of manipulating proficiency tests. An entirely new and equally important layer surrounding the controversy are the complex laws regulating innovations around laboratory testing. A great summary of this layer is from a Wired article that ran this last Tuesday.
But Theranos isn’t required to show its data to anyone except the occasional government inspector because it is regulated by a special set of rules that effectively let clinical labs police their own tests. Called the Clinical Laboratory Improvement Amendments, these regulations were meant to strike a balance between in-lab innovation and government-sanctioned safety. But as diagnostic tests evolve, the FDA worries that the rules are too permissive to protect patients. The agency is proposing updates that could prevent abuses like the ones Theranos has been accused of, and worse. But the new rules could also destroy diagnostic research’s pace of innovation, and gut the health care industry of many of its successful tests. Fixing the Laws That Let Theranos Hide Data Won't Be Easy ‒ Wired
By its own admission, the Company has now run over 3.5 million blood tests through a variety of processes and equipment. Some of those blood draws and tests were using the more traditional method of venipuncture and glass tubes, but others were using the Theranos finger‒stick method for drawing a few drops of blood into a tiny micro‒vial they call "nanotainer's." As of today, the FDA has only approved one test for Herpes Simplex using the Theranos developed finger‒stick and micro‒vial method. The back‒end equipment used to test either method ‒ regular or nanotainer vials ‒ is totally opaque.
Which brings us full circle to the litigation that may be necessary to sort this out. As I said ‒ I'm not an attorney ‒ but I am a consumer and I did buy a Theranos blood test in July that was not the FDA approved one and yet it did use the finger-stick and micro-vial method developed by the company. Here's a picture of my blood sample in two of the Theranos micro‒vials.
I simply have no idea what equipment or method was used to test my sample. I think it's equally safe to say that other people ‒ as part of the 3.5 million tests to date ‒ also have no idea what equipment was used for their test either.
If the company elects to rely on FDA approval as the sole mechanism for public trust, do they not have some obligation to disclose the method and equipment used for non‒FDA approved tests?
Adding to the controversy, the company announced ‒ just last week ‒ that their finger-stick, micro-vial method of drawing blood would only be used for the one test approved by the FDA. That means that blood drawn today at a Theranos clinic ‒ unless it's for Herpes Simplex ‒ is likely to use the traditional venipuncture and vial ‒ at least until further FDA approvals (pending) for each of the 200 tests offered by Theranos.
Do I have any confidence in the results of my test? In a word ‒ no. Why should I? Others, who have also taken a Theranos test, have stepped forward challenging the accuracy ‒ with compelling evidence. The most notable is a venture capitalist who calls Palo Alto (where Theranos is headquartered) home. His name is Jean‒Louis Gassée and he writes weekly for Monday Note. For his last article ‒ Theranos Trouble: A First Person Account ‒ he shared the results from several tests he had taken to compare Theranos and Stanford Hospital's Hematology Lab.
He wrote a letter to Elizabeth Holmes directly ‒ which he shared in his article. The reply? Silence.
In the end, it seems that our collective assurance as consumers rests entirely on the proclamations of the company. Trust us ‒ except that we wish to remain entirely opaque relative to the tried and true method of scientific peer‒review, and we have no obligation to respond directly to evidence of inaccuracy by consumers. We also have no obligation to disclose which back‒end equipment was approved for use by the FDA ‒ for which test, and which back-end equipment was part of regularly scheduled (and industry standard) proficiency testing.
Violating rules around proficiency testing isn't new. In 2013, the Ohio State University lab settled with the feds to the tune of $268,000.
It was announced in June 2012 that the OSU lab ran afoul of the Centers for Medicare and Medicaid Services (CMS) after it self-reported it had violated the rules governing proficiency testing. Apparently six proficiency testing samples sent to OSU were forwarded to the Mayo Clinic and other labs within the OSU system, which is prohibited by federal law. The tests reportedly included Lyme Disease testing and blood cultures. The problems with proficiency testing in this lab date back to November 2009.
Is there any way for Theranos to gain consumer trust for test results without litigation? I'm not seeing it ‒ but again ‒ I'm not an attorney. I was just curious about a new method for drawing and testing blood. The consumer experience for drawing the blood was definitely frictionless and transparent, but the process for actually testing it is more opaque than ever.
