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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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On-demand Video Service Hulu Gets Underway on TV Miniseries Documenting Rise and Fall of Former Theranos CEO Elizabeth Holmes

Six-episode show is based on popular ABC Radio podcast “The Dropout,” which focused on the three-year investigation that brought down clinical laboratory test developer Theranos

While former Theranos CEO Elizabeth Holmes awaits the start of her August 31 criminal fraud trial in a federal court in Northern California, one streaming video service is lining up a star-studded cast to tell the story of the Silicon Valley executive’s fall from grace and the demise of her clinical laboratory blood-testing company.

This six-part series is being produced by Hulu, an on-demand video streaming service offering live and on-demand content. Back in 2019, it announced that it would produce the “The Dropout,” a limited series chronicling Holmes’ rise and fall from Founder and CEO of $9 billion tech company Theranos to criminal defendant.

Hulu says the series will launch this fall, so pathologists and medical laboratory managers have time to set their recorders to capture what may be a compelling story of hubris that took investors and the news media on a wild ride. The Theranos publicity machine was so effective that many hospital CEOs went to their clinical laboratory administrators and told them to delay equipment purchases because Theranos would be able to do the same medical laboratory tests at just pennies on the existing lab-cost dollar.

Holmes’ carefully-crafted public image as Theranos’ CEO drew comparisons to the late Apple CEO Steve Jobs, Business Insider noted. This has made her a popular topic not only among clinical laboratory scientists but also Hollywood moviemakers.

“The Dropout” took its inspiration from the ABC Audio podcast of the same name, hosted by ABC Chief Business, Technology and Economics correspondent Rebecca Jarvis. The ABC Audio podcast’s description provides a glimpse into the direction the miniseries will take.

“Money. Romance. Tragedy. Deception. The story of Elizabeth Holmes and Theranos is an unbelievable tale of ambition and fame gone terribly wrong. How did the world’s youngest self-made female billionaire lose it all in the blink of an eye? How did the woman once heralded as ‘the next Steve Jobs’ find herself facing criminal charges—to which she pleaded not guilty—and up to 20 years in jail? How did her technology, meant to revolutionize healthcare, potentially put millions of patients at risk? And how did so many smart people get it so wrong along the way?” the ABC Audio website states.

The Hulu series originally was to star “Saturday Night Live” cast member Kate McKinnon as Holmes but was recast with Amanda Seyfried in the starring role. According to Variety, the series will include a notable lineup of guest stars including:

Naveen Andrews will play former Theranos President and COO Ramesh Balwani, whose own criminal fraud trial is expected to begin early next year.

A release date for the limited series has not yet been announced, Town and Country reported.

Elizabeth Holmes

Elizabeth Holmes (above), former CEO of now defunct company Theranos, faces 11 counts of fraud for alleged false claims that the clinical laboratory testing company had created a revolutionary finger-prick technology capable of performing a wide range of clinical laboratory tests. Among the charges are two counts of conspiracy to commit wire fraud and nine counts of wire fraud, for which Holmes could serve up to 20 years in jail if found guilty of all charges, according to court documents. She has pleaded not guilty. (Photo copyright: The Wall Street Journal.)

The ‘Real World’ Wall Street Journal Investigation of Theranos and Holmes

Dark Daily has reported extensively on the Holmes/Theranos saga, including the recent development that Holmes’ repeatedly-delayed trial would be pushed back from mid-July to August 31 because Holmes is due to give birth in July.

Theranos’ alleged deceptions first were brought to light in a series of 2015 investigative reports in The Wall Street Journal (WSJ). Then-WSJ investigative reporter John Carreyrou alleged Theranos had not disclosed publicly that the vast majority of its tests were not being done with proprietary technology, but instead with traditional machines purchased from Siemens AG and other companies.

Carreyrou’s reporting became the basis for his bestselling book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup,” which led to “The Inventor: Out for Blood in Silicon Valley,” a 2019 HBO documentary film.

And for those looking for even more drama centered around the Theranos saga, a feature film starring Jennifer Lawrence as Elizabeth Holmes, titled, “Bad Blood,” remains “in development” according to People magazine. Though the project was announced in 2016, filming has yet to begin.

Meanwhile, clinical laboratory scientists will soon get to watch the next “real world” chapter in the Holmes’ saga play out in federal court later this summer. They will also have multiple opportunities in the coming years to be “entertained” by the Theranos scandal on big and small screens.

—Andrea Downing Peck

Related Information

‘The Dropout’: William H. Macy, Laurie Metcalf, Elizabeth Marvel, Utkarsh Ambudkar, Kate Burton Among 10 Cast in Hulu Limited Series

Here Are All the Ways Theranos CEO Elizabeth Holmes Has Imitated Steve Jobs Over the Years

Elizabeth Holmes Hulu Series ‘The Dropout’ Adds 10 Guest Stars, including William H. Macy, Laurie Metcalf, Stephen Fry

U.S. v. Elizabeth Holmes, et al.

Hot Startup Theranos Has Struggled with Its Blood Test Technology

Amanda Seyfried to Play Elizabeth Holmes in Hulu Series ‘The Dropout,’ Taking Over from Kate McKinnon

Former Theranos CEO Elizabeth Holmes Is Pregnant, Causing a Further Delay in Her Trial Date

Federal Prosecutors Signal That Accuracy of Theranos’ Blood Tests Will Be Centerstage in August Fraud Trial

Pregnant former Theranos CEO Elizabeth Holmes makes her first court appearance in 15 months as pre-trial maneuvering continues in court case involving clinical laboratory tests

During pre-trial hearings for the August fraud trial of former Theranos CEO, Elizabeth Holmes, federal prosecutors signaled that the accuracy of Theranos’ blood tests will be center stage in their arguments. This latest installment in the continuing saga of defunct medical laboratory testing company Theranos took place when a now-pregnant Holmes made her first in-person court appearance in 15 months.

Clinical laboratory scientists have watched with interest as the often-delayed fraud trial inched closer to its new August 31 start date. After being delayed multiple times by the COVID-19 pandemic, United States District Court Judge Edward Davila ruled in March that the trial would be postponed from mid-July to late August due to Holmes’ pregnancy. She is due to give birth in July.

Do Prosecutors Lack Proof Theranos’ Blood Testing Technology Is Inaccurate?

As Dark Daily previously reported, Holmes faces 12 counts of wire fraud charges for alleged false claims that Theranos created a revolutionary technology for performing a wide range of clinical laboratory tests using a tiny amount of blood.

In its 2015 investigative report, The Wall Street Journal (WSJ) alleged Theranos had not disclosed publicly that the vast majority of its tests were performed with traditional machines purchased from Siemens AG and other companies, not its so-called breakthrough proprietary technology.

The recent three-day hearing provided Holmes’ attorneys and federal prosecutors with an opportunity to present arguments regarding what evidence can be presented at the upcoming trial.

In a recent article, the WSJ reported that Holmes’ attorneys argued the US Attorney’s Office for the Northern District of California built its case on anecdotal evidence.

According to the WSJ article, Holmes’ defense team is trying to block the government from calling patients and medical professionals to testify about the accuracy of Theranos’ blood test results. At the hearing, attorney Amy Saharia, a Williams and Connolly LLP partner, maintained prosecutors lack scientific proof Theranos tests were inaccurate. She called this lack of scientific evidence a “gigantic hole” in the government’s case.

“This trial is going to be a sprawling mess of irrelevant, prejudicial evidence,” she told the court, the WSJ reported.

Saharia added, “We have all become very familiar with testing this year. Testing involves many different variables,” CNBC reported. “What the government offers is without scientific basis, they have to establish Theranos technology was responsible for erroneous results. Just because it happened doesn’t mean it was because of Theranos technology.”

pregnant-elizabeth-holmes-leaving-courthouse
Pregnant Elizabeth Holmes (above), who is due to give birth in July, is seen entering the courtroom for a pretrial hearing in San Jose, Calif., in the US government’s fraud case against the former Theranos CEO. In the hearing, federal prosecutors indicated the accuracy of Theranos’ clinical laboratory tests will be at the center of their arguments. (Photo copyright: Mercury News.)

Defense Tries to Block Pathologists’ Testimony

During the second day of hearings, federal prosecutors responded to defense attorneys’ efforts to block clinical pathologist Stephen Master, MD, PhD, from testifying. Defense attorneys argued the government is using Master as a “parrot” and argue his views on Theranos’ blood tests are “based on emails and customer complaints” not personal familiarity with the tests, CNBC reported. Master is Division Chief and Director, Metabolic and Advanced Diagnostics at Children’s Hospital of Philadelphia, and an Associate Professor of Pathology and Laboratory at University of Pennsylvania’s Perelman School of Medicine.

Assistant US Attorney Robert Leach, however, said, “Miss Holmes went out, told the world and told investors: we have tests with the highest accuracy rate,” adding that testimony from their expert witness “puts the lie to that,” CNBC reported.

Before Theranos was dissolved in 2018, Holmes rose to rock star status in Silicon Valley. She graced magazine covers, rubbed elbows with VIPs, and became known for her Steve Jobs-like signature black turtleneck.

In his summary of Holmes’ 2016 presentation at the annual meeting of the American Association of Clinical Chemistry (AACC), titled, “After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology,” Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, wrote, “It would be safe to summarize most reactions as skeptical.”

Holmes’ presentation, Michel noted, was met with suspicion as her credibility with the media and clinical laboratory scientists eroded. “Holmes did not fool many in the audience.”

One clinical chemist who attended the AACC meeting said, “I came to see scientific data about this remarkable technology that could do up to 70 medical laboratory tests on a single drop of capillary blood. Instead, I heard her talk about the new corporate strategy at Theranos, including the details as to how their analyzer works. The data that followed had nothing to do with anything but their new analyzer.”

Prosecutors Claim Fraud Paid for Holmes’ Extravagant Lifestyle

Holmes’ celebrity status helped fuel Theranos’ rapid valuation growth, which reached a high of $10 billion in 2015. But her gold-plated lifestyle became a point of contention during the recent pre-trial hearing. Prosecutors maintained that Theranos’ fraud propelled Holmes’ extravagant spending.

“In addition to her salary, the company provided for her luxurious travel on private jets and expensive lodging,” Assistant US Attorney John Bostic told CNBC. “The point here is the so-called success of Theranos was entirely the product of fraud.”

But according to CNBC, the judge “pushed back” on the government’s argument, stating Holmes’ benefits likely were on par with other CEOs. “What’s the value that she’s at the Four Seasons or a Motel 6?” the judge asked the prosecutors.

CNBC reported the two sides also sparred over whether jurors will learn about Holmes’ private text messages and regulatory reports.

Holmes and former Theranos President and Chief Operating Officer Ramesh Balwani have both pleaded not guilty. Balwani will face a separate trial after Holmes’ court case concludes.

Clinical laboratory scientists will watch with interest as the Holmes and Balwani trials finally get under way, since the accuracy of Theranos’ blood tests will be under the microscope along with Holmes’ participation in the alleged fraud.

Andrea Downing Peck

Related Information:

Elizabeth Holmes Makes First Courtroom Appearance in Over a Year

Hot Startup Theranos Has Struggled with its Blood-Test Technology

Elizabeth Holmes Lavish Lifestyle Looms over Theranos Fraud Case

Accuracy of Theranos Blood Tests at Heart of Elizabeth Holmes’ Criminal Case

Elizabeth Holmes Reappears in Court for First Time in 15 Months Putting Silicon Valley Culture Under Scrutiny

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of its TechnologyFederal Prosecutors Add a 12th Felony Fraud Charge in Latest Criminal Indictment Against Theranos Founder Elizabeth Holmes

Multi-national Gathering of Clinical Laboratory Professionals Assesses Benefits and Problems with Point-of Care Testing in Toronto this Week

Pathologists and medical laboratory professionals heard speakers from Sweden, Australia, New Zealand, and Canada discuss the latest developments in POCT

TORONTO, ONTARIO—Spirited discussion always results when pathologists and clinical laboratory professionals discuss point-of-care testing (POCT). That was certainly true during a special POCT workshop that took place here this week.

Attendees came from as far away as Sweden, Australia, and New Zealand to attend “Point-of-Care Testing: Today and Tomorrow.” The conference was produced by the Toronto-based Institute for Quality Management in Healthcare (IQMH).

Point-of-Care Testing Has an Essential Role in Patient Care

As most medical laboratory scientists know, POCT can be both a blessing and a curse. When used properly, POCT plays an essential role in patient care and can guide physicians in ways that improve outcomes. However, problems associated with the ongoing management and performance of an organization’s POCT program regularly frustrates laboratory scientists tasked with oversight of POCT. (more…)

Why Smartphones May Be the Best Business Opportunity in Healthcare

Pathologists take note: 80% of physicians will be using mobile technology by 2012

Meet “mHealth!” That’s the new term to describe how mobile devices are used in the delivery of healthcare to patients. Many clinical laboratories and pathology groups already have laboratory informatics solutions that support how their client physicians use mHealth solutions in patient care.

Experts predict that Smartphones will dominate mobile healthcare (mHealth) in just a few short years. The enabling tools will be mobile applications (apps) that monitor such conditions as diabetes, hypertension, coronary heart disease and asthma. Smart phones will also be used to order medical laboratory tests and access clinical laboratory test data.
(more…)

Shrinking Computer Chips Expand Market for Point-of-Care Handheld Devices

Siemens AG has introduced a PDA-sized portable ultrasound machine dubbed the P10 that allows emergency room doctors to assess patients quickly and easily. Devices like the P10 are possible largely because analog chip makers are racing to develop electronics that allow portability. Like cell phones before them, these portable ultrasound machines will become increasingly smaller, faster, and cheaper over time. They will also consume far less power than their full-sized counterparts.

Technology advances like these will also trigger new, smaller analyzers for in vitro diagnostics. The explosive growth in this market is demonstrated by a simple fact: semiconductor sales associated with medical equipment totaled $3.02 billion in 2007, up 65% from 5 years ago! Sales of portable systems-those weighing less than 11 lbs-climbed 42% to $565 million last year and are forecasted to reach $1.2 billion in 5 years, according to Klein Biomedical Consultants, Inc., General Electric Co’s GE Healthcare, SonoSite Inc., and Zonare Medical Systems, Inc. together accounted for 85% of the market in 2007.

These portable devices are expected to make ultrasound, which has traditionally been limited to radiologists, cardiologists, obstetricians, and gynecologists, available to new classes of specialists, including anesthesiologists and emergency care physicians. The expanded use of ultrasound could help cut healthcare costs through earlier and more accurate diagnoses.

Technology incorporated in the P10 and other portable ultrasound devices does need improvement. For example, the P10 currently does no show color, so doctors won’t see some problems. Its battery life is limited to four hours of normal use. Refinements to improve image quality and reduce power usage in the pipeline and will soon reach clinical use.

The refinement of computing chips for use in portable ultrasound devices is of note to laboratory staff because this technology has easy applications in creating more and better portable laboratory testing devices. That will expand the types of near patient and point-of-care (POC) testing systems available for diagnostic purposes. It will also enable a new generation of patient self test systems to find ready acceptance by patients. In fact, the development of blood glucose monitoring systems for diabetic patients provides one good example of how manufacturers are regularly adding new features and capabilities to these consumer self-test products.

Related Articles:
Chip Advances Lift Ultrasound Market, Help Save Lives

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