Though crystal ball gazing’s often a fool’s game, Theranos’ steady stream of recent debacles make such a prediction more likely than not. Apart from what regulators such asand FDA may decide, investors pulling the plug and/or partners like Walgreens walking away could easily precipitate such unraveling. However, whether or not that happens, shouldn’t the circumstances that led to such unraveling remain the focus of our attention?
What about potential wrongdoing?
- If regulators never inspected Edison, Theranos’ proprietary machine, how did it get -certified?
- If Edison wasn’t CLIA-certified, how could Theranos run patient blood samples on it?
- If they did run patient blood samples on non-CLIA-certified Edison(s), isn’t that a violation of US federal government regulations since use of patient blood draws need to follow CLIA guidelines?
- If Edison wasn’t CLIA-certified, and Theranos ran patient blood samples on it, doesn’t it become research use instead?
- Doesn’t such research use blood draw require the patient’s informed consent and in turn an approved ?
- Did Theranos appropriately account for such research use patient blood draw by applying for and receiving an approved IRB for blood tests done on Edison?
Whether Theranos stays or goes, careful analysis of the issues raised by WSJ, FDA, CMS and other investigations make these as yet unanswered questions necessary to answer in the public interest. After all, should suspicion of serious violation of federal health care regulations just stay unanswered if the company in question falls by the wayside? And these are not all.
- Why was Theranos hyped so much by the popular media? No peer-reviewed studies, no independent, conflict of interest-free scrutiny of its proprietary technology and data by credible scientists. In short, none of the accepted gold standards of theoretically impartial scientific scrutiny.
- Was popular science journalism merely credulous or irresponsible or rather was it about adhering to an unwritten rule to never question one of Silicon Valley’s anointed ones? Are any of these even acceptable excuses? After all, this is about pubic health, not the latest electronic gadget.
- Theranos may go or stay but what about some necessary mea culpa within popular science journalism, its overseers and stakeholders? Though many noted sites hyped Theranos, only a handful (Forbes, Fortune for e.g.) have since publicly subjected themselves to necessary soul-searching.
- Doesn’t this bode ill, pun intended, for those who might submit their medical samples to the next healthcare disruptor darling and then haplessly pay too high a price for wrong diagnoses or treatments that may inevitably follow?