A recent article discussed the problems that Theranos has been having from both a professional and PR perspective (see: PR lessons from the Theranos debacle: Defend the science). One of the major key points is that Theranos has failed to "defend its science" and also failed to produce a "respected medical ally" that could assist the company is its defense against critics. There have been a multitude of calls over previous weeks for Theranos to produce its data for validating the accuracy of its proprietary analyzer. For me, this is just another way of asking the company to defend its science. Below is an excerpt from the article:
Throughout the [Theranos] debacle Holmes has been front and centre, not shying away from the assault. And while some PR professionals have interpreted this as a display of strength, Janet Vasquez [from JV Public Relations] thinks “it hasn’t been enough and ”[She] could have done more.".... Ms.Vasquez points out that the main value behind companies such as Theranos lies in the science behind them. When that’s attacked, it must be protected. And by not producing a respected medical ally with the right credentials to defend Theranos and its science,...the CEO committed a significant PR faux pas....“Theranos failed in effectively defending its science. ”Theranos is still standing ━ on top of a tidy little $9-billion valuation, no less ━ but the slings and arrows keep coming...."
All of this calls into question of why Theranos has not been unwilling or unable to defend its science thus far. I have come up with three possible reasons:
- In order the defend the science, it would be forced to reveal details about its proprietary analyzer to its competitors.
- The company is well able to defend its science but it does not think that such a defense, even if adequate, would quiet its critics.
- The maturity of its science and technology has lagged behind its marketing campaign and it is thus unable to defend its science at this time.
For me, only the third reason strikes me as reasonable. At the present time, only one Theranos test, herpes (HSV-1), has been approved under the 510(k) premarket approval process of the FDA by comparing it to a predicate device (see: THERANOS HERPES SIMPLEX VIRUS-1 (HSV-1) IgG ASSAY). However, even that particular test can't be performed in its own labs because its nanotainer, used to collect and store blood samples, has been classified by the FDA as a Class II device and needs clearance for interstate commerce (see: Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device).
Theranos is both a reference lab and an IVD manufacturer. For the sake of this discussion, I will proceed on the assumption that it is mainly operating as the latter in the eyes of the FDA. It needs to apply for 510(k) approval for all of the analytes that it wants to perform on its analyzer. The company has suggested that this process will be relatively routine but I have my doubts given the complexity of the problem. However, I can say one thing for certain at this time. The major path for defending its science runs through the FDA.