Jurors are expected to hear closing arguments beginning on December 16 and then will decide Holmes’ fate in criminal fraud trial
It was seven days of testimony from former Theranos CEO Elizabeth Holmes, reported in detail by most major news outlets. The jury in her criminal fraud trial heard the once-high-flying Silicon Valley executive attempt to explain away charges of deception. She acknowledged that she made mistakes while leading the clinical laboratory blood-testing company but claimed that others were ultimately responsible for the company’s failures.
Rosendorff left Theranos in November 2014. He was followed by three more Theranos laboratory directors, all of whom have testified in the fraud case against Holmes.
Presumably, in her testimony, Holmes was laying the blame for key failures in the accuracy of the lab tests performed for patients, along with major deficiencies in how her medical lab company complied with CLIA regulations, on these former Theranos laboratory directors (as the clinical laboratory company’s CLIA lab directors of record during those years).
“Whether you have an intent to defraud is really a state of mind,” she said.
‘We Wanted to Help People’
Holmes’ testimony may have both helped and hurt her case. According to The Wall Street Journal (WSJ), Holmes “hasn’t flinched during questioning by her lawyer or the government.
“The persona of the confident yet traumatized chief executive could create reasonable doubt in the minds of jurors, legal observers following the trial say, and muddy the evidence prosecutors put forward over 11 weeks to prove she intended to defraud investors and patients about the reach of Theranos’ technology,” the WSJ wrote.
During testimony, Holmes maintained that her goal in founding Theranos was to increase access to healthcare. “We wanted to help people who were scared of needles,” she told jurors, the WSJ reported.
In building its case, prosecutors presented witness testimony and other evidence strongly suggesting Holmes lied to investors about Theranos’ laboratory testing capabilities and deployment, concealed its use of commercial blood testing machines, and hid ongoing issues with its Edison device.
One of the most damaging moments of Holmes’ own testimony may have been when she admitted to affixing the logos of pharmaceutical giants Pfizer and Schering-Plough to reports sent to Walgreens and potential investors.
Holmes told jurors that her intent was to give credit to others, not to deceive and her defense attorneys attempted to show that many of Holmes’ more questionable decisions were aimed at protecting Theranos trade secrets.
“We had a huge amount of invention that was happening in our laboratories,” Holmes testified, according to CNN’s trial coverage. “We had teams of scientists and engineers that were working really hard on coming up with new ideas for patents and trade secrets, and we needed to figure out how to protect them.”
Holmes Claims No Responsibility for Theranos’ Lab Operations and Product Development
On the witness stand, Holmes acknowledged she was the final decisionmaker at Theranos. However, she worked to distance herself from the company’s medical laboratory troubles. She pointed out that others within the company had control over laboratory operations and scientific decision-making.
The WSJ reported that defense lawyer Kevin Downey asked Holmes, “Who was responsible for operational management of the lab?”
Holmes replied, “Sunny Balwani.” She explained that her former No. 2 executive oversaw all the “business parts” of the lab. Meanwhile, the clinical/scientific decision-making, Holmes stated, was the job of the laboratory director and laboratory leadership.
When given the opportunity to cross-examine Holmes, prosecutors focused on Holmes’ response to the 2015 WSJ investigation into Theranos and her retaliatory actions against whistleblower Erika Cheung, a former lab employee who became a source for the WSJ’s expose and a prosecution witness.
According to WSJ live coverage, Holmes testified that Theranos hired a law firm and threatened Cheung with litigation after she left the company, but only did so to protect Theranos’ trade secrets. Holmes acknowledged that Cheung’s concerns about Theranos’ blood-testing technology ultimately were proven correct.
“I think I mishandled the entire process of the Wall Street Journal reporting,” Holmes said.
Closing Arguments
In her closing day of testimony, Holmes was asked if she ever intentionally misrepresented Theranos’ technology to patients and investors, the WSJ reported.
“Never,” Holmes responded.
Asked if investors lost money because of her attempting to mislead them, she answered, “Of course not.”
Clinical laboratory directors and pathologists who have taken a keen interest in the Holmes fraud trial will soon learn if the jury buys her arguments. Closing arguments are set for December 16, after which the jury must decide whether Holmes intended to defraud patients and investors or is guilty only of falling short in her goal of revolutionizing clinical laboratory medicine.
WSJ reporter affirms that the pathologist was his “first and most important source” in confirming the problems at the now-defunct medical lab testing company
During the federal fraud trial of Theranos Founder and former-CEO Elizabeth Holmes, no one has spent more days on the witness stand than ex-Theranos Laboratory Director Adam Rosendorff, MD, the pathologist who testified for the prosecution that he repeatedly warned Holmes about problems with Theranos’ flawed Edison blood-testing device.
Dark Daily’s previous ebrief on the ongoing Holmes’ fraud trial reported that Rosendorff, who is board certified in clinical pathology, had testified, “I told her that the potassium was unreliable, the sodium was unreliable, the glucose was unreliable, [and] explained why. She was very nervous. She was not her usual composed self. She was trembling a bit, her knee was tapping, her voice was breaking up. She was clearly upset.”
It should come as no surprise that in response Holmes’ lawyers attempted to paint Rosendorff as an “incompetent” lab director with a resume littered with failures at other biotech companies. According to court documents, Holmes faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for allegedly misleading investors, clinical laboratories, patients, and healthcare providers about Theranos’ proprietary blood-testing technology.
But the many clinical laboratory professionals closely watching the Holmes trial will be equally interested to learn that outside of the courtroom former Wall Street Journal (WSJ) reporter John Carreyrou confirmed on Twitter that Rosendorff was the main source for his 2015 investigative reporting—which first called into question Theranos’ claim that it could run more than 200 blood tests using a finger-prick of blood—as well as for his subsequent book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”
Carreyrou Declares Ex-Theranos Lab Director Adam Rosendorff a Hero
“So, I’ve been fielding queries from reporters asking me to confirm that former Theranos lab director Adam Rosendorff, who is currently testifying at Elizabeth Holmes’ trial, was my source. I can now confirm it. Alan Beam = Adam Rosendorff,” Carreyrou tweeted.
“I’ll add this: Adam was my first and most important source. Without him, I wouldn’t have been able to break the Theranos story. Hats off to his courage and integrity. He’s one of the real heroes of this story,” Carreyrou added in a subsequent Tweet.
Inside the San Jose, Calif., courtroom, pathologist Rosendorff took centerstage, completing six days on the witness stand as Holmes’ defense attorney Lance Wade, JD, sought to undermine Rosendorff’s earlier testimony for the prosecution and question his competence as a laboratory leader.
Rosendorff Testifies About Another CMS Investigation at Lab Where He is Medical Director
Rosendorff acknowledged during cross examination that he risked losing his license as a lab director after the CMS inspectors uncovered testing deficiencies at PerkinElmer’s Valencia (California) Branch Laboratory as well, where Rosendorff currently serves as Laboratory and Medical Director.
According to the WSJ, Rosendorff testified that most of the CMS inspection involved reviewing documents. During cross examination, it was revealed that the same CMS inspectors who investigated Theranos also conducted the PerkinElmer lab investigation.
Defense attorneys also had hoped to question Rosendorff about his previous work at uBiome Inc., a startup that was the target of a 2019 federal probe into its lab test billing practices, CNBC reported.
The Mercury News reported that during an October 5 hearing to determine the extent to which Holmes’ legal team could cross examine Rosendorff about his past employment, Wade told US District Judge Edward Davila that Rosendorff had a failed record as a lab leader. The Holmes defense lawyer alleged a link between “unreliable test results” at the biotechnology company Rosendorff went to after leaving Theranos and claimed that Rosendorff’s work at PerkinElmer resulted in the CMS notice of “serious deficiencies” at the lab.
“[Rosendorff] pointed the finger at many other people, including my client,” Wade told Davila. “He appears to almost never have competently done his job. He was incompetent at Theranos, too, and that is the reason many of the failures happened. He’s the person who’s ultimately responsible in the laboratory,” he added.
Nevertheless, Judge Davila prohibited questions regarding Rosendorff’s employment at uBiome and limited the scope of questions about his current role at PerkinElmer.
Holmes’ Attorneys Challenge Rosendorff’s Testimony During Cross Examination
After leaving Theranos, Rosendorff’s LinkedIn profile shows he served as Laboratory Director at San Francisco-based Invitae from December 2014 to September 2017 before moving to Millennium Health in San Diego as Medical Director from December 2017 to January 2021. He joined PerkinElmer in January.
The WSJ reported that Rosendorff’s ties to uBiome showed up in Theranos court records.
The WSJ also noted that during the multiday cross examination of Rosendorff, the Holmes defense team scored points by “pointing to contradictions in his testimony and challenging his assertions that he wanted to expose Theranos’ testing practices to the government.”
In making his point, Wade read aloud from a deposition Rosendorff gave during a separate case in which he claimed that Theranos did not have a greater number of anomalous test results than other labs where he had previously worked.
“And that’s 180 degrees from what you answered in your direct testimony,” Wade said to Rosendorff during cross examination.
“Yes, it seems to be different,” Rosendorff replied, but also noted that Theranos should have fewer errors than a lab with a much higher volume of tests.
Wade also introduced a November 2014 email in which Rosendorff told a colleague he knew of only one time when Theranos provided to a patient an obviously incorrect test result. Rosendorff had previously testified that he alerted Holmes on numerous occasions about his concerns with ongoing testing errors.
Wade also questioned whether Rosendorff had a financial motive for considering a whistleblower lawsuit against Theranos, pointing out that Rosendorff would be entitled to a portion of any damages recovered. Rosendorff responded that he did not have a profit motive in mind when he forwarded more than 150 Theranos emails to his personal account.
Former WSJ Reporter Carreyrou May Be Called to Testify
Clinical laboratory managers and pathologists will be fascinated with another twist that surfaced as this trial continued. Former WSJ reporter Carreyrou became personally intertwined with the Holmes’ trial after it came to light that the investigative reporter—whose podcast “Bad Blood: The Final Chapter” spotlights the ongoing fraud trial—is on Holmes’ potential witness list.
The motion, The Mercury News reported, states that “Placing Carreyrou on the witness list was done in bad faith and was designed to harass him,” and calls his placement on the list “a cynical ruse” that violates Carreyrou’s First Amendment rights.
CNN reported that Carreyrou’s attorneys are asking that the exclusion order (which prevents some witnesses from being inside the courtroom during other witness testimonies) or the gag order (which allows witnesses to discuss their testimonies only with their attorneys) not be applied to Carreyrou.
For clinical laboratory scientists awaiting the next installment in the now six-week-old trial, former Safeway CEO Steven Burd (now founder and CEO of Burd Health) will continue his testimony on the failed partnership between the grocery store chain and Theranos.
The Theranos agreement with Safeway is not as well-known as the Theranos-Walgreens deal. This was another news story written by Carreyrou and published by the WSJ on Nov. 10, 2015, titled, “Safeway, Theranos Split after $350 Million Deal Fizzles.”
As part of that agreement, Safeway spent $350 million to remodel 800 of its grocery stores to have a patient service center (PCS) and laboratory space where the unproven Edison device would be used to perform the clinical laboratory tests.
The testimony in this next phase of trial about the Safeway agreement with Theranos, and Holmes’ role in convincing the Safeway executive team to invest a third of a billion dollars to build 800 PSCs and lab spaces in 800 stores, should be as interesting as the witness testimony given earlier in this trial.
Pole-to-pole sampling of marine life leads researchers to conclude the world’s oceans could hold the key to many scientific and biotechnological advancements
Virologists and microbiologists will be intrigued to learn that scientists at Ohio State University (OSU) have identified nearly 200,000 previously unknown viruses living deep in the oceans. The catalog of 195,728 viruses could serve as a “road map” to a better understanding of ecosystems within the world’s oceans and the role they play in maintaining the health of the planet.
Though the research was not specifically directed at developing useful insights for clinical care, it could one day lead to new diagnostic assays or therapies. For clinical laboratories and anatomic pathology groups, this study demonstrates how understanding and knowledge about viruses and other organisms continue to grow.
The researches published their findings in the journal Cell.
Viruses Are Tiny but Important
The OSU researchers led a 24-member team’s effort to expand
the catalog of ocean viruses and draw the first global map of viral diversity.
“Viruses tend to steal genes and do really interesting
things with them. So, someone who’s savvy in biotechnology can mine this data
set to find new enzymes that can help us in our everyday lives, whether that’s
cosmetic products or creating a new thermocycler or some sort of engineering
process,” Matthew
Sullivan, PhD, a microbiologist at OSU and one of the study’s authors, told
CNN.
According to the news release, “The samples were collected during the unprecedented three-year Tara Oceans Expedition, in which a team of more than 200 experts took to the sea to catalog and better understand the unseen inhabitants of the ocean, from tiny animals to viruses and bacteria.”
“What was really exciting was now being able to study these viruses at two important levels—the population level and by looking at genetic variation within each population, which tells us about evolution,” Ann Gregory, PhD, co-lead author of the study, said in an OSU news release. “We have expanded the number of known viral populations more than tenfold and this new map will help us understand the impact of ocean viruses on a global level,” she added.
A news release from Tara Ocean Foundation notes that prior ocean surveys had identified 16,000 viral species.
Massive Quest for Knowledge
The OSU scientists studied ocean life from varying ocean depths, stretching from pole to pole, using samples collected during the Tara Oceans expeditions, which took place from 2009-2013. The Tara Ocean Foundation has backed 11 scientific expeditions and collected more than 60,000 samples that have been the basis for more than 70 scientific publications.
The team of researchers split the viruses into five
ecological zones: all depths of the Arctic and Antarctic and three distinct
depths of the Temperate and Tropical regions, noted the OSU study.
By developing new methods to sequence viruses in planktonic
populations, the OSU research team, according to the Tara Ocean press release,
was able to understand genetic variations:
Between individuals within each population;
Between populations within each viral community;
and
Between communities across several environments
of the global oceans, as well as study the driving forces behind all these
variations.
In its news release, Tara Ocean Foundation pointed out one
surprise was the “cradle of viral diversity” found in the Arctic Ocean, which
had not been part of earlier studies of ocean life.
“This research has significant implications for
understanding how ocean micro-organisms affect the atmosphere,” Sullivan said
in the Cell Press news release, which goes on to note that, “The investigators
say that having a more complete picture of marine viral distribution and
abundance will help them to determine which viruses they should be focusing on
for further studies.”
“Previous ocean ecosystem models have commonly ignored
microbes, and rarely included viruses, but we now know they are a vital
component to include,” said Sullivan.
At this time, the OSU study offers little that clinical
laboratories can use other than a deeper awareness of how viruses impact our
world and environment. However, further study of the ocean depths may yield
surprises that also expand medical knowledge and lead to new therapies and
diagnostic tests.
New study conducted by an international team of researchers suggests that artificial intelligence (AI) may be better than highly-trained humans at detecting certain skin cancers
Artificial intelligence (AI) has been working its way into health technology for several years and, so far, AI tools have been a boon to physicians and health networks. Until now, though, the general view was that it was a supplemental tool for diagnosticians, not a replacement for them. But what if the AI was better at detecting disease than humans, including anatomic pathologists?
Researchers in the Department of Dermatology at Heidelberg University in Germany have concluded that AI can be more accurate at identifying certain cancers. The challenge they designed for their study involved skin biopsies and dermatologists.
They pitted a deep-learning convolutional neural network (CNN) against 58 dermatologists from 17 countries to determine which was more accurate at detecting malignant melanomas—humans or AI. A CNN is an artificial network based on the biological processes that occur when neurons in the brain are connected to each other and respond to what the eye sees.
The CNN won.
“For the first time we compared a CNN’s diagnostic performance with a large international group of 58 dermatologists, including 30 experts. Most dermatologists were outperformed by the CNN. Irrespective of any physicians’ experience, they may benefit from assistance by a CNN’s image classification,” the report noted.
“I expected only a performance on an even level with the physicians. The outperformance even of the average experienced and trained dermatologists was a major surprise,” Holger Haenssle, PhD, Professor of Dermatology at Heidelberg University and one of the authors of the study, told Healthline. Anatomic pathologists will want to follow the further development of this research and its associated diagnostic technologies. (Photo copyright: University of Heidelberg.)
Does AI Tech Have Superior Visual Acuity Compared to Human Eyes?
The dermatologists who participated in the study had varying degrees of experience in dermoscopy, also known as dermatoscopy. Thirty of the doctors had more than five-year’s experience and were considered to be expert level. Eleven of the dermatologists were considered “skilled” with two- to five-year’s experience. The remaining 17 doctors were termed beginners with less than two-year’s experience.
To perform the study, the researchers first compiled a set of 100 dermoscopic images that showed melanomas and benign moles called Nevi. Dermoscopes (or dermatoscopes) create images using a magnifying glass and light source pressed against the skin. The resulting magnified, high-resolution images allow for easier, more accurate diagnoses than inspection with the naked eye.
During the first stage of the research, the dermatologists were asked to diagnose whether a lesion was melanoma or benign by looking at the images with their naked eyes. They also were asked to render their opinions for any needed action, such as surgery and follow-up care based on their diagnoses.
After this part of the study, the dermatologists on average identified 86.6% of the melanomas and 71.3% of the benign moles. More experienced doctors identified the melanomas at 89%, which was slightly higher than the average of the group.
The researchers also showed 300 images of malignant and benign skin lesions to the CNN. The AI accurately identified 95% of the melanomas by analyzing the images.
“The CNN missed fewer melanomas, meaning it had a higher sensitivity than the dermatologists, and it misdiagnosed fewer benign moles as malignant melanoma, which means it had a higher specificity. This would result in less unnecessary surgery,” Haenssle told CBS News.
In a later part of the research, the dermatologists were shown the images a second time and provided clinical information about the patients, including age, gender, and location of the lesion. They were again instructed to make diagnoses and projected care decisions. With the additional information, the doctors’ average detection of melanomas increased to 88.9% and their recognition of benign moles increased to 75.7%. Still below the results of the CNN.
These findings suggest that the visual pattern recognition of AI technology could be a meaningful tool to help physicians and researchers diagnose certain cancers.
“In the future, I think AI will be integrated into practice as a diagnostic aide, particularly in primary care, to support the decision to excise a lesion, refer, or otherwise to reassure that it is benign,” Victoria Mar, PhD, an Adjunct Senior Lecturer in the Department of Public Health and Preventative Medicine at Australia’s Monash University, told Healthline.
“There is the potential for AI technology to be integrated with 2D or 3D skin imaging systems, which means that the majority of benign lesions would be already filtered by the machine, so that we can spend more time concentrating on the difficult or more concerning lesions,” she said. “To me, this means a more productive interaction with the patient, where we can focus on appropriate management and provide more streamlined care.”
AI Performs Well in Other Studies Involving Skin Biopsies
This study is not the only research that suggests entities besides humans may be utilized in diagnosing some cancers from images. Last year, computer scientists at Stanford University performed similar research and found comparable results. For that study, the researchers created and trained an algorithm to visually diagnose potential skin cancers by looking at a database of skin images. They then showed photos of skin lesions to 21 dermatologists and asked for their diagnoses based on the images. They found the accuracy of their AI matched the performance of the doctors when diagnosing skin cancer from viewed images.
While many dermatologists read patient biopsies on their own, they also refer high volumes of skin biopsies to anatomic pathologists. A technology that can accurately diagnose skin cancers could potentially impact the workload received by clinical laboratories and anatomic pathology groups.
Syracuse, New York, aims to position itself as the healthcare destination of choice for Ontarians right across the border who are weary of waiting for free healthcare from their provincial health service
There is a new twist in medical tourism! United States hospitals are advertising to Canadians who are frustrated by increasingly long waiting times for elective medical procedures from their national health service. U.S. providers are hoping to lure them across the border for quicker access to care.
Until recently, U.S. hospitals were not motivated to attract Canadian patients as a way to generate new admissions. However, years of sustained cuts to prices paid to U.S. hospitals by health insurers have made it economically attractive for U.S. hospitals to advertise to Canadian patients just across the border. The medical laboratories of American hospitals serving medical tourists benefit from this source of patients.
Number of Canadians Coming to U.S. for Medical Care Each Year Growing
While Canadians get most of their medical care for free through a nationwide, single-payer system administered by each province, thousands of Canadians come to the U.S. each year seeking medical care. In 2014, an estimated 52,513 Canadians received non-emergency medical treatment outside Canada. The largest number of patients leaving the country for healthcare are from the Province of Ontario and total 26,252, according to the Fraser Institute, a Canadian research organization. The number of Canadians seeking medical care outside the country’s borders was up 26% from a year earlier, the study showed. (more…)