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Clinical Laboratories and Pathology Groups

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Skeptical Missouri Pathologist Played a Key Role in Wall Street Journal Reporter John Carreyrou’s Expose´ Of Medical Lab Test Company Theranos

Fawning media coverage Theranos’ blood-test claims ended once experts spoke out, showing the importance of strong relationships between pathologist and journalists

Wall Street Journal (WSJ) reporter John Carreyrou’s investigation into former Silicon Valley darling Theranos is credited with turning the spotlight on the blood-testing company’s claims and questionable technology. However, Carreyrou’s investigation may never have happened without the assistance of Missouri pathologist Adam Clapper, MD, who tipped off the reporter to growing skepticism about Theranos’ finger-stick blood testing device.

Clapper’s involvement in Theranos’ fall from grace provides a lesson on why anatomic pathologists, clinical pathologists, and other medical laboratory leaders should cultivate strong working relationships with healthcare journalists who seek out expert sources when covering lab-related issues.

Dark Daily has written extensively about Theranos—once valued at nine billion dollars—and its founder and former CEO Elizabeth Holmes, whose criminal trial on nine counts of wire fraud and two counts of conspiracy to commit wire fraud is scheduled to begin this summer, noted the WSJ.

In 2018, Holmes and former Theranos President Ramesh “Sunny” Balwani settled a civil case with the Securities and Exchange Commission (SEC). Holmes agreed to pay a $500,000 penalty and relinquished control of Theranos. She also was barred from serving as Director of a public company for 10 years.

Theranos Investigation Would Not Have Occurred without Clapper

Holmes founded Theranos in 2003 when she was 19 years old. By 2013, Holmes had become a media sensation based on her claims that Theranos had developed a medical technology that could run thousands of clinical laboratory tests using the blood from a tiny finger-prick. And, she claimed, it could do so quickly and cheaply.

By 2015, Carreyrou’s exposé in theWall Street Journal revealed Theranos’ massive deceptions and questionable practices. His series of stories kickstarted the company’s downfall. However, Carreyrou acknowledges his investigation would not have occurred if it were not for pathologist Clapper.

“Without Adam Clapper, I am almost 100% sure that I wouldn’t have done anything,” Carreyrou told the Missourian. “It was the combination of him calling me and telling me what he had found out and how he felt and my feelings about the New Yorker story that really got me on the call of this scandal,” he said.

Anatomic and clinical pathologist Adam Clapper, MD (above), became skeptical about Holmes’ claims after reading a profile on her in The New Yorker. In December 2014, Clapper ended a post on his now defunct Pathology Blawg by saying, “Until proven otherwise, I’m going to be skeptical of Theranos’ claims.” That comment became a starting point for Carreyrou’s later investigation into Theranos. (Photo copyright: Missourian.)

According to the Missourian, Clapper turned to Carreyrou because the reporter had impressed him as “very fact-oriented and fact-driven” during telephone interviews for a series Carreyrou had written the year prior on Medicare fraud.

“I could hear his wheels spinning in his head as we were talking the first time, then he definitely sounded interested and intrigued,” Clapper told the Missourian. “And then I could tell he was even more so because very soon thereafter—like half an hour after that initial conversation—he’d already started to do some research into Theranos.”

Ten months later, the WSJ published Carreyrou’s first installment of his series on Theranos.

“The fact that this tip originated from a guy in Columbia, Missouri, thousands of miles from Silicon Valley—who never spoke to Elizabeth Holmes, who had no connection to the company or even to Silicon Valley other than he read about her claims in a magazine and knew a lot about this by virtue of being a pathologist—tells you that the people who put in all the money in [Theranos] didn’t spend enough time talking to experts and asking them what was feasible and what wasn’t,” said Carreyrou.

Benjamin Mazer, MD (above), an anatomic and clinical pathology resident in pathology and lab medicine at Yale New Haven Hospital, argues pathologists’ voices were noticeably—and critically—absent from media coverage during Theranos’ decade-long ascension. “For many of us in the pathology community, the writing was on the wall long before Carreyrou’s article was published,” he wrote in Health News Review. “Had journalists consulted pathologists as expert sources, the news coverage of Theranos might have been less fawning and more skeptical. Patients might have been spared erroneous tests.” (Photo copyright: Yale University.)

The lawyers defending Holmes against criminal fraud charges are contending Carreyrou “went beyond reporting the Theranos story” by prodding sources to contact federal regulators about the company’s alleged frauds and “possibly biased the agencies’ findings against [Theranos],” Bloomberg News reported.

The Wall Street Journal, however, stands behind Carreyrou’s reporting, which later was published as book, titled, “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”

Carreyrou told New York Magazine he doesn’t blame reporters for hyping Holmes and the technology she touted.

“You could make a case that maybe they should have done more reporting beyond interviewing her and her immediate entourage,” he said. “But how much is a writer/reporter to blame when the subject is bald-face lying to him, too?”

Nonetheless, the Theranos scandal offers a lesson to pathologists and clinical laboratory professionals in the importance of building good working relationships with healthcare journalists who not only must accurately report on healthcare breakthroughs and developments, but also need someone they can trust for an unbiased opinion.

—Andrea Downing Peck

Related Information:

Blood, Fraud and Money Led to CEO’s Fall from Grace

Theranos Founder Elizabeth Holmes to Face Trial Next Year on Fraud Charges

Theranos, CEO Holmes, and Former President Balwani Charged with Massive Fraud

Hot Startup Theranos Struggled with Its Blood Test Technology

The Pathologist and ‘The Inventor’: How a Columbia Doctor Helped Take Down Theranos

Blood Simpler

Elizabeth Holmes Blames Journalist for Theranos Troubles

Pathologists Predicted the Theranos Debacle, but their Voices Were Missing from Most News Coverage

The Reporter Who Took Down a Unicorn

Online Negative Reviews Can Threaten Clinical Laboratories Not Prepared to Address Feedback or Manage Their Internet Presence

As consumers increasingly choose physicians and service providers based on other people’s feedback on review websites, Internet-based customer service programs are becoming critical business tools for clinical laboratories and pathology groups

Clinical laboratory managers are becoming increasingly aware that negative reviews on anonymous online review sites, such as Yelp and others, can negatively impact revenues.

Official sources and surveys, such as Medicare’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), already provide information and ratings on healthcare service providers. However, recent coverage in Healthcare Dive highlights how consumers are finding the narrative reviews on websites such as Yelp more accessible and relatable. And, that these reviews focus on the criteria consumers find most important.

“We’re moving to a health system where patient ratings are becoming more important, [one] where top-down ratings are really inaccessible to patients and probably not that useful,” Yevgeniy Feyman, PhD, told Healthcare Dive. Feyman, along with Paul Howard, PhD, co-authored the Manhattan Institute report, “Yelp for Health.”

In the report, they examined the correlation between Yelp reviews of New York hospitals and objective measures of hospital quality. “We find that higher Yelp ratings are correlated with better-quality hospitals and that they provide a useful, clear, and reliable tool for comparing the quality of different facilities as measured by potentially preventable readmission rates (PPR), a widely accepted metric,” they stated.

This is a significant finding for clinical laboratory administrators and pathologists. It demonstrates that how patients review their provider experiences does align with objective measures of provider quality that may be public, but are not as easy for consumers to find as websites like Yelp, Healthgrades, and others.

Online Reviews: A Metric for Determining Healthcare Value and Quality?

Andrea Ducas, Senior Program Manager with the Robert Wood Johnson Foundation (RWJF), told Healthcare Dive the primary considerations patients use to pick providers include:

  • “Treats patients with respect;
  • “Accepts insurance;
  • “Shares in decision-making;
  • “Responsiveness to phone calls; and,
  • “Professional skill.”

Research into how patients find/choose their physicians conducted by OnePoll and commissioned by Binary Fountain determined that, of more than 1,000 adults surveyed:

  • “95% of respondents regard online ratings and reviews as ‘somewhat’ to ‘very’ reliable;
  • “75% of Americans say online ratings and review sites have influenced their decision when choosing a physician; and,
  • “30% of consumers share their own healthcare experiences via social media and online ratings and review sites.”

Common research sources listed by respondents included:

Can Online Reviews Damage Healthcare Providers?

“Given that the majority of quality measures out there … aren’t really that accessible for patients, this is a very good proxy,” Feyman told U.S. News in a report on physicians’ concerns about the use and popularity of review sites.

“[T]he emphasis placed on a small number of patient opinions—far fewer patients leave reviews than are treated in a typical health system—makes it harder for doctors to do their job for fear of a career-harming bad review. And a few negative posts from disgruntled patients could unfairly skew public perception—and eventually, a provider’s bottom line,” U.S. News noted.

Despite this, Luther Lowe, Yelp’s Senior Vice President of Public Policy and Government Affairs, assured Healthcare Dive they have processes to “filter spam and quell suspicious activity daily.”

Online reviews recently played an important role in the Wall Street Journal (WSJ) exposé on Theranos, which Dark Daily covered in 2016. Investigative reporter John Carreyrou (above) used Yelp to locate patients who reported negative experiences with specific healthcare services and practices. He described how he used the platform during a presentation to the Association of Health Care Journalists (AHCJ) in April 2018. Click on this link to watch a video of Carreyrou’s presentation. (Photo copyright: Association of Healthcare Journalists.)

Negative Reviews: A Critical Concern for Medical Laboratories

Consumers continue to use Internet platforms to both share ratings and compare information on healthcare professionals and the clinical laboratories supporting them. Thus, to prevent damage from negative reviews, labs must actively monitor feedback, pursue inaccurate information posted online, and encourage consumers to provide positive feedback and opinions.

According to data from Alexa, Yelp is the 32nd most visited website in the United States. Yelp’s own data reports that more than 150-million reviews have been added to the site since its inception 13 years ago.

And, Yelp categorizes 7% of the reviewed businesses as “health-related.”

Between easy-to-access information distributed online and an increased push for transparency, clinical laboratories and other healthcare service providers must work to take charge of the narrative created about their businesses and encourage positive feedback on these developing platforms.

Failing to do so could cost laboratories the physicians’ practices they service.

“There are some providers who are trying to get ahead of the curve and post reviews directly on their website,” Ducas told Healthcare Dive. “Another thing they can do is encourage their patients to read some reviews online and invite them to leave feedback. That’s a radical invitation but it’s certainly something they can do.”

As healthcare customers increasingly turn to review sites for feedback about healthcare facilities and the service providers supporting them, clinical laboratories and anatomic pathology groups must focus on their Internet presence and respond quickly to any negative review feedback with great customer service.

—Jon Stone

Related Information:

Providers Jittery over ‘Yelpification’ of Healthcare

Highlights from the Healthcare Consumer Insight and Digital Engagement Survey

Yelp Proving to Be Reliable for Hospital Reviews, Addresses 12 More Measures than HCAHPS Scores

Using Yelp for Your Health

Most Top Hospital Online Reviews Are Lukewarm or Negative

Hospitals That Receive Top Marks in Quality Rankings Earn Mediocre Reviews Online, Analysis Finds

Study: Nearly 63% of Yelp Reviewers Give Top-Ranked Hospitals Mediocre to Poor Ratings

Study Suggests Yelp Can Help People Find Quality Healthcare

Yelp for Health: Using the Wisdom of Crowds to Find High-Quality Hospitals

Federal Appeals Court Rules Yelp Not Responsible for Bad Reviews; Labs Advised to Examine Their Online Presence

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device. (more…)

Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry

Honors highlight concern among public and press over potential harm to patients of the medical laboratory industry and the need for more transparency in the quality of care delivered by pathologists and lab scientists

John Carreyrou, Investigative Reporter, and Mike Siconolfi, Senior Editor, both with The Wall Street Journal (WSJ), took home the prestigious National Institute for Health Care Management (NIHCM) Foundation Journalism Award on Monday, May 2, for their work covering Theranos, Inc.

This is the third time this year Carreyrou has won the award in the General Circulation Print Journalism category for his work covering Theranos, the embattled clinical laboratory company in Palo Alto, Calif., owned by CEO Elizabeth Holmes.

(more…)

CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

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