A bid by a lawyer for Elizabeth Holmes to discredit a doctor testifying about inaccurate blood test results backfired Thursday during the felony-fraud trial for the Theranos founder.
Defense attorney Katie Trefz was cross-examining Dr. Mark Burnes, who testified that his patient in 2015 received two erroneous Theranos blood test results indicating possible prostate cancer. The patient had gone to an Arizona Walgreens for Theranos testing and received prostate-specific antigen (PSA) results more than 10 times his actual levels, Burnes testified.
After Burnes told jurors that he recommends that all his patients over 50 get tested for prostate cancer via the PSA test, Trefz asked: Was the doctor aware that the American College of Physicians in 2013 warned that patients should discuss with their doctors the “limited benefits and substantial harms” related to the PSA test before getting it?
“I disagree with the recommendation,” Burnes snapped back. One risk from PSA testing is the possibility that an inaccurate result could lead to an un-needed medical intervention, he told jurors. “You might unnecessarily send a patient for a biopsy,” Burnes testified.
The warning from the physicians college says such biopsies require “multiple needles being inserted into the prostate” and carry a small risk of infection, significant bleeding or hospitalization.
Subsequent testing showed that Burnes’ patient actually had normal PSA levels, the jury heard.
Burnes acknowledged under cross-examination that he knows lab errors occasionally occur, and that he has had an issue unrelated to Theranos with patients’ test results being mixed up.
Also on Thursday, a journalist described a series of apparent misrepresentations Holmes made to him, several of which appeared in a Fortune magazine article that jurors have heard was highlighted by Theranos to investors.
During a series of interviews with Holmes in the months before the 2014 publication of the Fortune magazine article — promoted on the cover with a photo of Holmes and the headline “This CEO’s Out For Blood” — the Theranos founder told journalist Roger Parloff her company could conduct more than 200 tests and was working on offering many more. “We have a single device that can perform any test,” Holmes told Parloff in an audio clip played for the jury.
Jurors heard earlier from a former Theranos lab director that the company used modified blood analyzers from other companies, including the German firm Siemens, for tests its own machines could not perform. Parloff testified that he asked Holmes specifically about whether Theranos was using Siemens analyzers. “She said, ‘Uh-uh,’ ” he testified. “It was a non-verbal response, but it meant … ‘We don’t do that.’ ”
Prosecutors allege that Theranos’ own machines could only conduct a dozen different tests, and the company had been using third-party analyzers since launching commercial blood testing in 2013. Included in a presentation Theranos sent to Parloff was a menu of tests the company claimed it provided, including the “complete blood count” or CBC test.
“Did Ms. Holmes ever tell you that the Theranos-built analyzer didn’t have the parts necessary to run the CBC test?” prosecutor John Bostic asked. Parloff replied: “No.”
Holmes, who founded the Palo Alto blood-testing startup at age 19 in 2003, is charged with allegedly bilking investors out of hundreds of millions of dollars and defrauding patients with false claims that the company’s machines could conduct a full range of tests using just a few drops of blood, when she knew the technology had serious accuracy problems. She and her co-accused, former company president Sunny Balwani, have denied the allegations. Balwani is to be tried next year.
The presentation sent to Parloff contained a claim that Theranos testing had “the highest level of accuracy,” and Parloff testified that that assertion was in line with what Holmes had told him. Bostic asked Parloff if Holmes had told him that previously a Theranos lab director, Dr. Adam Rosendorff, had quit after repeatedly raising concerns about the accuracy of the company’s tests; Parloff said she had not.
Holmes also sent Parloff two reports, both praising Theranos’ technology, that bore apparently stolen logos from pharmaceutical giants Pfizer and Schering-Plough. Investors testified earlier that they believed the reports, sent to them by Theranos, represented validation of Theranos’ testing by those companies. Bostic asked Parloff whether Holmes told him that the reports were generated by Theranos; he said no.
Regarding Theranos’ claims that its machines needed small amounts of blood drawn from a finger-stick, Bostic asked Parloff if Holmes told him that about 40% of Theranos customers at Walgreens drug stores had to have their blood taken from their veins using needles. “No,” Parloff said.
Holmes, charged with a dozen counts, faces maximum penalties of 20 years in prison and a $2.75 million fine if convicted, plus possible restitution, the Department of Justice has said.
