Case vs. Theranos troubling

Of greatest importance now in the criminal case involving the Silicon Valley, Calif., blood-testing company Theranos is not whether the company’s two leaders will receive adequate punishment if convicted.

Rather, the immediate concern must be whether any of the medical patients who were victims of the company’s alleged misdeeds suffered serious or irreparable harm as a result of the unconscionable conduct of which the company is accused.

Within the scope of what’s humanly possible, there needs to be an audit of the cases that Theranos handled, with the goal of identifying negative impacts attributable to the company.

For now, regarding the two company leaders charged — founder Elizabeth Holmes and the former president and chief operating officer Ramesh “Sunny” Balwani — it must be hoped that a court of law eventually will mete out appropriate punishment — again, if guilt is proven or guilty pleas are entered.

The importance of blood tests for medical patients cannot be overstated.

People here are well aware of that. If the company indeed did not perform tests as it was required to do — and evidence compiled to date seems to indicate that — those responsible deserve no leniency by any court.

Quoted in last weekend’s Wall Street Journal, John F. Bennett, special agent in charge of the Federal Bureau of Investigation in San Francisco, said, “This indictment alleges a corporate conspiracy to defraud financial investors. More egregiously, this conspiracy misled doctors and patients about the reliability of medical tests that endangered health and lives.”

Holmes, a Stanford University dropout, claimed to have invented new technology that could run the full range of laboratory tests on just a drop or two of blood pricked from a finger.

However, as the Journal revealed in a series of articles beginning in October 2015, Theranos’ blood-testing device was unreliable, and the company used it for just a fraction of the 240 kinds of tests that it offered.

According to last weekend’s Journal article, Theranos, behind the scenes, performed the vast majority of the tests that it purportedly was carrying out with its new testing technology with commercial analyzers purchased from other companies.

“Moreover, Theranos modified some of those commercial analyzers in ways that neither their manufacturer nor the federal health agency overseeing Theranos had authorized,” the Journal said. “The modifications … led to inaccurate test results, according to former Theranos employees.”

Prosecutors allege that Holmes and Balwani, both of whom face up to 20 years in prison, knew that many of their representations about their analyzer were false, that the analyzer had accuracy and reliability problems, actually performed just a limited number of tests, was slower than some competing devices and, in some respects, could not compete with existing, more conventional testing devices.

Responding to pressure from federal health regulators, Theranos voided or corrected nearly a million blood-test results and also agreed to reimburse 76,000 people of Arizona who used its blood-testing services after it rolled out its tests in California and Arizona.

But those steps are insufficient. There’s still a need to determine — and reveal to the people of this country — how many patients actually were harmed by Theranos’ alleged criminal behavior and how severely.

Without that data, the Theranos case can’t be brought to proper closure.