Final prosecution witnesses at Holmes trial describe tests and misleading statements – NBC Bay Area
Arizona dentist set to leave the country for two years of missionary work in 2015 had to undergo four tests for prostate cancer after his doctor ordered him to have blood drawn at a Theranos site at a Walgreens store.
Testifying Thursday in the criminal fraud trial of Elizabeth Holmes, founder and CEO of the now defunct blood testing company Theranos, Arizona doctor Mark Burnes said he sent his patient, a dentist named Mehrl Ellsworth, at the Walgreens down the street because the test required for the trip was not covered by insurance and the Theranos method would be cheaper than conventional labs.
But cheaper turned out not to be better.
Theranos’ first result showed an unusually high prostate antigen level of 26.1. Anything above a value of 4 can be of concern, Burnes said, although increasing patient numbers year over year is a better metric.
Burnes ordered a second test, also administered by Theranos, which returned to a more normal level of 1.71. But a third Theranos test, carried out after Dr Burnes spoke to the regional director of the Theranos lab in an attempt to resolve the conflicting results, came down to 22.8. At this point, said Burnes, he told Theranos he wanted the screening to be done using a traditional venous pull, and not the finger method used in the first three tests and presented by Theranos. as a revolutionary blood test option.
The fourth test, worth 0.95, left Burnes “more reassured” about his patient’s health.
He said he believed the first and third tests were due to Theranos’ lab errors, a suspicion that was confirmed in the spring of 2016 when he received a notice from Theranos overriding both of these results.
Holmes is charged with 12 counts of wire fraud based on allegedly false and misleading statements made to investors, doctors and patients about the now defunct company’s blood testing technology.
Filling in some gaps in the evidence as the prosecution ends, Assistant U.S. Attorney Jeffrey Schenk pointed to the fact that Ellsworth’s test results were faxed from Theranos to the Burnes Arizona office.
The transmission of laboratory blood results for the “ME patient” is the basis of one of the wire fraud counts in the indictment, each of which requires some form of interstate wire communication. .
In cross-examination of Burnes, Holmes defense attorney Katherine Trefz asked if the area code “650” listed for Theranos’ fax number meant the fax was from Arizona, leaving Californians in the North in the courtroom scratching their heads since 650 is an area code on the Peninsula.
When Trefz asked Burnes if errors could occur in a clinical lab, Burnes said such errors were “very rare.”
Trying to take the risks of the prostate screening tests, Trefz then asked, “You don’t always recommend [the prostate] test for men over 50, right? “Burnes replied,” Yes, I do. “
When it was Schenk’s turn again, Burnes said the main risk with prostate screening was “an inaccurate result.”
Another count of wire fraud in the indictment was supplemented by testimony from patient Erin Tompkins on Wednesday about a false positive HIV result she received from Theranos.
During cross-examination on Thursday, Trefz showed Tompkins a complex decision tree for interpreting HIV tests, asking Tomkins “See that?” Against each step. Tomkins, who testified that she had no medical training, could only admit that she could, in fact, see the file.
The rest of the day was devoted to the long-awaited testimony of Roger Parloff, the Fortune magazine writer who did a cover story in June 2014 that catapulted Holmes and Theranos into the public eye.
Prosecutor John Bostic explained to Parloff a series of statements from Holmes, which the jury heard either on tapes made by Parloff or on documents she sent him, which could have been a summary of the government’s charges.
Holmes told Parloff that Theranos can run “any test available” in conventional labs, has over 200 tests running using fingers and proprietary analyzers, and will soon offer ” more than 1,000 ”, that the tests provided“ the highest level of quality ”, and that the technology“ had been used by the military in Afghanistan ”.
Holmes also sent Parloff two separate “validation” reports, one with the Pfizer logo and the other purportedly from Schering-Plow, which previous witnesses said were created by Theranos and never endorsed by those companies.
The tapes reflect a bemused Parloff trying to figure out why, with so many tests supposedly available using a finger, many patients undergoing Theranos tests at Walgreens were having their blood drawn through their veins.
Holmes, in one of the many elaborate explanations heard on the tapes, said that although all patients’ blood tests were analyzed on Theranos machines, venous samples were sometimes needed “to manage the volume”, due to ” the capacity that we have in these systems at any given time. “
The trial will continue on Friday.