Since WSJ did not walk back from any of the assertions it made in its reporting, no. The relevant take-away from Theranos’ Elizabeth Holmes’ interview at WSJ.D Live on Wed, Oct 21, 2015 and Theranos’ point-by-point rebuttal of Wall Street Journal’s (WSJ) Oct 15-16, 2015 reports is WSJ’s responding press release which states,
Nothing said at the conference by Ms. Holmes refutes the accuracy of the reporting done by John Carreyrou or of the articles, which were subject to the Journal’s rigorous and careful editing process’ and that ‘Theranos subsequently posted a lengthy rebuttal to the articles the Journal published last week. We carefully reviewed the company’s claims; nothing in Theranos’s report undermines the accuracy of the articles. (1).
WSJ’s reporting suggests extremely troubling legal implications for how Theranos could be using patient/volunteer blood samples.
Typically, we give our blood samples under three different circumstances, each of which is governed by different laws and regulations, based on how it will be used:
- Volunteer to donate blood? Sign in, undergo health history and mini-physical, donate and leave (2). The blood bank tests the donated blood for presence of or exposure to disease agents as required by law. If donated blood passes those tests, it’s cleared for use in transfusions.
- Get blood drawn for tests based on doctor’s advice? Here the blood is being drawn for clinical blood diagnostics, not for research use. No ifs ands or buts. What does that mean though? It means the blood will be sent to a clinical blood testing lab. In the US, such blood should be processed in labs using
In the US, accuracy of this blood testing process is administered by the regulatory agency,(CMS). CMS has two responsibilities, one, to accredit clinical blood testing labs, and two, to administer and oversee the mandatory Proficiency Tests (PTs) that each CLIA-accredited clinical blood testing lab in the US has to routinely undergo 3 times a year. These tests are mandated by law to ensure that their test results are accurate.
(CLIA) guidelines that oversee clinical blood testing procedures. The samples are then run on CLIA-certified machines which spit out the results. Eventually, the patient and patient’s doctor’s office receive the results.
Research use of patient/volunteer blood samples
- I mentioned three different circumstances, didn’t I? That’s where I suspect the legal brouhaha over Theranos will eventually focus and here’s why.
- To me, WSJ’s reporting suggests that Theranos was a clinical blood testing lab on paper but may have ended up operating as an R&D lab in practice.
- If I am correct in this deduction, that’s an undesirable position for Theranos. Why? For that we need to delve into the third circumstance under which we donate blood and that’s for research purposes.
- Given the heinous history of human experimentation, Mengele during the WWII Holocaust and the Tuskegee Syphilis project in the US, for example, there are strict laws and regulations governing human research.
- Blood samples from a research subject require their .
- This is turn requires the blood sample seeking entity to draft a research proposal and get it approved by an independent (IRB) (3). Such a proposal needs to outline in detail the purpose for which the blood is being taken, the kinds of procedures and tests the blood will be subjected to, and what use will be made of the data that’s generated from such tests.
- If the IRB is sought by a private entity, not an academic institution or medical facility, typically it will partner with local hospitals/clinics/blood centers who would co-sign such proposals and whose role in the process is to help administer and oversee the research blood collection, following the rules and regulations mandated by the law.
Taking patient/volunteer blood samples for clinical versus research use
- If I’m right in my suspicion that Theranos was a clinical blood testing lab on paper but may have ended up operating as an R&D lab in practice, it’s possible that some of the use of blood samples collected at all those Walgreen’s Theranos Wellness Centers could have been in violation of existing laws. How?
- If Theranos took such blood samples and routinely ran them in in-house developed proprietary machines that were not CLIA-certified or never subjected to CLIA oversight, such processes become research, and not clinical, use. Such research use is fine as long as such blood samples were obtained from people who gave informed consent to such research use under the purview of an IRB-approved research protocol.
- It then follows logically to ask if, in addition to CLIA-accreditation, Theranos also had an IRB-approved research protocol? And was blood taken from people at Walgreen’s Theranos Wellness Centers after they gave informed consent, as required for an IRB-approved research protocol? Answers to these may turn out to be a crucial inflection point in the investigation on Theranos.
Testing patient/volunteer blood samples on CLIA-accredited commercial machines versus Theranos’ in-house developed proprietary machines
- Why were Theranos staff instructed to run state-mandated PT samples on commercial machines and not on their in-house developed proprietary machines? This is what the Oct 15, 2015, WSJ article alleges (4).
- Commercial machines that run state-mandated PT samples and pass the tests are CLIA-certified and approved for clinical blood testing. If Theranos was routinely doing this, that’s fine and legal.
- If however, after taking patient blood samples obtained at Walgreen’s Theranos Wellness Centers, Theranos was running only such samples but not state-mandated PT samples on their in-house developed proprietary systems, that would be breach of the law because such machines wouldn’t be CLIA-certified, and therefore, such use of clinical material becomes research use.
- If patients/volunteers who walked into Theranos Wellness Centers to give their blood samples never gave their informed consent for such research use, and if such research use of their blood samples was never sought under the purview of an IRB-approved research protocol, it becomes illegal use of their blood samples or at least that’s how I interpret it.
- If this was routine, it could become the crux of a huge legal problem for Theranos.
Role of CMS in Theranos’ CLIA-accreditation
- That’s not all. Since it got CLIA-accreditation, whenever that was, how was Theranos maintaining it?
- Was it maintaining it only for the traditional machines it bought, e.g., Siemens, or also for the proprietary machines it developed in-house? If the latter, how did it do so, since the Oct 15, 2015, WSJ article alleges PT sample results run on such machines ‘were off‘ (4), and further that Theranos staff were instructed to stop running state-mandated PT samples on Theranos’ in-house developed proprietary machines (4).
- Maintaining CLIA-accreditation requires passing annual PTs. Did Theranos maintain passing grades for both commercial machines it purchased and for its own in-house developed proprietary machines or only for the former?
- If only for the former, was CMS aware of this discrepancy? If not, why not?
- If Theranos wasn’t running state-mandated PT samples on their in-house developed proprietary machines because such samples contained preservatives or other materials that interfered with those machines’ functioning, was CMS aware or made aware of such problems, and did Theranos and CMS work together to figure out alternative approaches to test the accuracy of Theranos’ proprietary machines?
- Answers to such questions would determine whether or not CMS also gets sucked into investigations about Theranos.
Theranos-Walgreens association: halt to expansion
Late on Fri, Oct 23, 2015, WSJ’s Michael Siconolfi, John Carreyrou and Christopher Weaver wrote that Walgreens, the drugstore chain, had decided to not open any new Theranos blood-testing centers until questions about its technology are resolved (5). Walgreens may now end up needing to do its own investigations of its partner, Theranos.
- The Wall Street Journal, Oct 21, 2015.
- The Wall Street Journal, John Carreyrou, Oct 15, 2015.
- The Wall Street Journal, Michael Siconolfi, John Carreyrou and Christopher Weaver, Oct 23, 2015.