Science is not discovering something new. It is not creating a medical miracle, nor is it a paradigm-shifting technological breakthrough. Science is a process: of asking questions, of testing your assumptions about those questions, and–this last part is very important–of documenting as accurately as possible the answers to those questions. All that other stuff is just what happens when you do science right.
Which is why, when you talk about Theranos, it is important that you do not get too hung up on their breakthrough technology, a machine called Edison that would allow up to 70 tests on a single drop of blood. Theranos is a blood testing company, and blood testing is a science–one that relies, yes, on machines, but really on people trained to operate those machines. It relies on those peoples’ ability to ask questions, test assumptions, and accurately record answers.
With regards to that last bit, Theranos has not been doing good science. Yesterday, the Centers for Medicare and Medicaid Services (or CMS, the government agency in charge of regulating clinical testing) released a pair of lightly redacted versions of earlier documents. Between the two, it’s pretty clear that Theranos had a lax scientific culture.
The document dump is huge. The first is a 150-page lab inspection report from last December detailing deficiencies at Theranos’ California testing lab. The second, a 45-page warning letter, puts those deficiencies in context. This statement–“The laboratory’s allegation of compliance is not credible and the evidence of correction is not acceptable”–appears nearly 45 times, in bold text. It shows up below referral codes to clinical lab guidelines, and above paragraphs outlining the nature of each discrepancy and Theranos’ inability to address it.
For the most part, each discrepancy is minor. Missing paperwork. Incomplete reports. Absent protocols. Unfollowed directions. Spoiled reagents. “My guess is if you went into any major lab and really scrutinized you’d come up with little things like this or that,” says Tim Hamill, medical director of UC San Francisco’s clinical labs at China Basin and Parnassus. “The fact that there are so many of them gives me the impression that these guys don’t know what they’re doing.”
That’s the same impression the CMS inspectors got. “In general, we find that the statements made in the allegation of compliance and evidence of correction … show a lack of understanding of the CLIA requirements,” says page 2 of the warning letter. CLIA stands for Clinical Laboratory Improvement Amendments, and they are the guidelines that let blood testing companies operate. Unlike pharmaceutical companies, which have to spend years making sure their drugs are both safe and effective, CLIA rules simply ensure that the people running the lab are competent.
Those rules are necessary because lab testing is always being revised and improved. CLIA is supposed to make sure each new test matches the quality of those that came before. “My whole job is to understand CLIA and make sure that we are meeting those rules,” says Ed Thornborrow, medical director of UC San Francisco’s clinical labs. “It would appear Theranos did not have somebody serving that role, or at least not doing it well.”
Theranos needs CLIA certification to survive. Without it, they cannot sell their tests through Medicare or Medicaid, which would pretty much end the company. In California, at least. And that lab is, for now, closed for procedural renovations to keep that certification.
But the company is still in business. Even when California was still a player, Theranos did 90 percent of its business in Arizona, where the company has 40 Walgreens testing centers. The catch is that lab does not use any proprietary technology. No Edison, no microfluidics, no breakthrough technology. Instead, the company runs its tests on boring old industry standards, while meeting the boring old government regulations.
Asked to explain what happened at the California lab, Theranos spokesperson Brooke Buchanan says, “Honestly, we didn’t have the right leaders in place.” In the past few months, Theranos hired a pair of new lab directors to reorganize the California lab. “We’ve taken the lab and its standard operating procedures down to their foundations and have been rebuilding everything over the past several months,” says Buchanan. Presumably, these two new lab directors will help the company push its proprietary technology closer to market.
If, that is, the company survives this round of federal scrutiny. The documents released yesterday spell out some harsh retributions if Theranos fails again to meet regs. Among the worst would be barring the company’s CEO, Elizabeth Holmes, and president Sunny Balwani from running any labs for the next two years. Which includes Arizona. “With regard to any hypothetical sanctions, we are still awaiting response from CMS,” says Buchanan. The company is also being investigated by the Securities Exchange Commission and Department of Justice to see whether its claims about revolutionary blood tests were misleading enough to constitute fraud towards its investors or the public.
Many questions, and the answers are coming slowly. But hey, that’s how you make sure the science works.