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Theranos lab problems posed ‘immediate jeopardy’ to patients: audit

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Elizabeth Holmes, the former chief executive officer of Theranos was dismissed following an appearance at San Jose federal court, California.

Stephen Lam | Reuters

SAN JOSE (CALIF.) — Kingshuk Das was Theranos’ lab director during the last two years. He claims that Elizabeth Holmes, CEO, ignored all his complaints regarding serious problems with Theranos’ blood-testing technology.

Das, who was a member of Theranos from late 2015 and reports directly to Holmes, testified on Tuesday during her criminal fraud case.

Holmes was able to understand the error issues by using the example of female patients who had abnormally high levels of prostate-specific antibody (or PSA) which is a test for prostate cancer.

Das stated that “Females shouldn’t have PSA detectable” but reminded Holmes of an alternative explanation. Holmes cited “an article or two”, claiming that rare breast cancers could cause PSA results for women.

“Was that explanation sufficient for you?” Robert Leach, an Assistant U.S. Attorney asked.

Das said, “It seemed absurd.”

Federal prosecutors claim that Holmes misled investors, doctors and patients about Theranos blood-testing technology. Holmes, once hailed as the next Steve Jobs faces up to twenty years imprisonment if she is convicted. Holmes pleaded guilty to the ten wire fraud charges and two conspiracy counts.

Das’ testimony may prove to be damaging. It reveals that Holmes knew that these tests weren’t reliable but continued to endorse them. During opening arguments and in cross examination of government witnesses, Holmes’ attorneys have painted her as a young, naïve CEO who was not aware of the inaccuracy issues.

Holmes was informed by Das that he had canceled all Edison device tests from 2014 to 2015, and that the Edison instruments “weren’t performing right from the beginning.”

Das explained that he tried to make it more understandable. I recall. [Holmes]”An alternative explanation was offered.” Das stated that Holmes had told him the incident wasn’t due to an instrument failure, but was rather related to quality control and quality assurance.

As lab director, Das testified that his first task was to respond to a finding in an audit by The Centers for Medicare & Medicaid Services.

CMS received a report on deficiencies from Sunil Dhawan (previous lab director at Theranos) in January 2016. This was after an inspection of Theranos’ laboratory. The subject read: “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.”

According to the report, “The on-site survey was concluded on November 20, 2015.” The survey revealed that the facility was not compliant with the conditions required to be certified under the CLIA program.

CMS determined that the deficient practices in the laboratory were a danger immediately to patient safety and health.

Holmes attorneys have tried to prevent the CMS report being presented to the jury. Judge overruled Holmes’ objection. Das stated that he had discussed with Holmes, Holmes, and others on his team the problems in the regulatory report.

Das was dismissed from the company by his employer in 2018. He continues his testimony on Wednesday.

Technology issues in the courtroom caused delays of over 2 hours. A video system used to display exhibits on screens in front of jurors and observers was broken. A projector from an old school was brought into courtroom. The lights were then dimmed so that the exhibits could be projected onto the wall directly across the aisle from the box.

U.S. District Court Judge Edward Davila declared, “I am very embarrassed that our courtroom has experienced these problems.” “I am sorry. This was not meant to happen. We should not be having these disruptions. We’ve lost valuable time.”

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