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.
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.
If direct-to-consumer testing continues to attract healthcare consumers and financial investors, medical laboratories could have a new source of revenue
Many have tried but few have found the right formula to
offer medical laboratory tests directly to consumers. Direct-to-consumer lab
testing as a robust business model has been an elusive goal. But now one
entrepreneur wants to crack this market and just attracted $50 million in
venture capital to fund her idea!
Outsiders often establish industries. This was the case when Jeff Bezos created Amazon in 1994. The online retailer transformed the way books were sold and, subsequently, established a massive new retail market.
Along the same lines, Julia Taylor Cheek, Founder and CEO of EverlyWell, a well-financed digital health company based in Austin—hopes to build a similarly disruptive business in the clinical laboratory industry.
Cheek is increasing her company’s outreach to consumers by
putting some of the company’s direct-to-consumer (DTC) medical tests on store
shelves at CVS and Target.
A former consultant and Harvard Business School graduate, Cheek raised $50 million in financing to expand EverlyWell’s digital platform. According to a news release, “Just two full years into operation, EverlyWell is reporting 300% year-over-year customer growth and a world-class consumer Net Promoter Score (NPS).”
“I think it’s a representation of sexism in our space. There are 15 other companies that have popped up in blood testing and you don’t hear anyone comparing Theranos to those male-founded startups,” she told Inc.
However, Dark Daily believes Cheek may be missing one
basis for the comparison with Elizabeth Holmes. Holmes intended for Theranos to
serve consumers with lab testing, and let consumers order and purchase their
own medical laboratory tests. Cheek is talking about the same primary business
strategy of letting consumers purchase their own lab tests.
Armed with this additional financing from investors, EverlyWell intends to expand services and develop new partnerships with retail pharmacy chain CVS Health (NYSE:CVS) and for-profit insurance company Humana (NYSE:HUM).
The news release notes, “The company has also expanded its
product line to offer 35 panels, including first-to-market tests in fertility,
vitamins, peri- and post-menopause, and high-risk HPV. In addition, EverlyWell
has launched an end-to-end care model for consumers, now offering an
independent physician consult and prescription, if appropriate, for select STDs
and Lyme Disease testing. All of this is included in an upfront price before
purchase.”
EverlyWell Intent on
Bringing Medical Laboratory Tests to Retail
Earlier this year, EverlyWell made nine lab tests available in more than 1,600 Target store locations, MedCity News reported. This may suggest that retailers are intrigued with direct-to-consumer lab testing.
“We didn’t create new tests or technologies. Instead, we’ve built technology that empowers people to get tests more easily. Our medical director works with the labs to create panels that are already validated and clinically relevant and understandable for consumers,” Julia Taylor Cheek (above), Founder and CEO of EverlyWell told Forbes. (Photo copyright: Arnold Wells/Austin Business Journal.)
Cheek reportedly established EverlyWell after becoming
disenchanted with medical laboratory tests that she felt were not well
explained and too costly under high-deductible health plans.
Just two years on, EverlyWell reports “hundreds of thousands of customers and tens of millions in sales.” The company plans to add additional staff on top of its existing 70 employees in anticipation of the new funding, Austin Business Journal reports.
“We are building a consumer brand, which means we have to be where people shop. We need to be in places like CVS and Target to really allow for broader distribution and name recognition,” Cheek told the Austin American-Statesman.
What Draws People to EverlyWell?
EverlyWell offers home health test kits, priced from $49 to
$400 that people can order without a doctor’s prescription and pay for online. Users
take their samples (saliva, urine, or a pinprick of blood) with provided
lancets and cotton swabs, MedCity News
reported.
EverlyWell’s top selling tests are:
Food sensitivity-$159;
Thyroid function-$159;
Metabolism-$89; and
Vitamin D deficiency-$99.
EverlyWell says it is “first” in direct-to-consumer tests
for:
EverlyWell Test kits come with registration information, instructions, collection tools;
Biological samples are sent by consumers to CLIA (Clinical Laboratory Improvement Amendments)-certified labs that partner with EverlyWell;
Results are generally completed within 10 days depending on type of test and business volume;
A physician reviews the test results;
Reports on test results are electronically accessible through smartphone apps and online web dashboards.
“Lab testing is arguably one of the most important steps in preventing and managing illness but has been largely ignored by digital health companies. EverlyWell is successfully navigating an entrenched industry to offer consumers an opportunity to take charge of their own health,” said Eric Kim, Managing Partner at Goodwater Capital (which led the financing), in the news release.
“We’re building the definitive technology-enabled healthcare platform that consumers deserve and have already come to expect in other areas of their lives,” Cheek told VentureBeat. “As high-deductible plans become the norm, consumers are becoming discerning buyers who look for seamless, digitally enabled experiences.”
Learning from
EverlyWell
Of course, pathologists and medical laboratory professionals
will watch to see if EverlyWell can sustain its rapid rise in popularity with
healthcare consumers. In particular, those consumers who prefer DTC testing
over traditional clinical laboratory visits and who may be on high-deductible
health plans.
The DTC test market represents an opportunity that most
clinical laboratories have yet to take seriously. There are many reasons why
medical lab managers and pathologists would be taking a “wait and see”
attitude. Meanwhile, EverlyWell has $50 million of investors’ money to use to
demonstrate the financial viability of its strategy to encourage consumers to purchase
their own clinical laboratory tests—and even collect their own specimens at
home!
This new technology could replace needle biopsies and allow physicians to detect rejection of transplanted organs earlier, saving patients’ lives
Anatomic pathologists
may be reading fewer biopsy reports for patients with organ transplants in the
future. That’s thanks to a new technology that may be more sensitive to and
capable of detecting organ rejection earlier than traditional needle biopsies.
When clinicians can detect organ transplant rejection
earlier, patients survive longer. Unfortunately, extensive organ damage may
have already occurred by the time rejection is detected through a traditional
needle biopsy. This led a group of researchers at Emory University School of Medicine to
search for a better method for detecting organ rejection in patients with transplants.
The Emory researchers describe the method and technology
they devised in a paper published in Nature Biomedical
Engineering, titled, “Non-Invasive Early Detection of Acute Transplant
Rejection Via Nanosensors of Granzyme B Activity.” The new technology could
make it easier for clinicians to detect when a patient’s body is rejecting a
transplanted organ at an earlier time than traditional methods.
This technology also provides a running measure of processes,
so clinicians have more powerful tools for deciding on the most appropriate
dosage of immunosuppressant
drugs.
“Right now, most tests are aimed at organ dysfunction, and
sometimes they don’t signal there is a problem until organ function is below 50
percent,” Andrew
Adams, MD, PhD Co-Principal Investigator and an Associate Professor of Surgery
at Emory University School of Medicine, in a Georgia
Institute of Technology news release.
How the Technology Works
The method that Adams and his colleagues tested involves the
detection of granzyme B,
a serine protease
often found in the granules of natural killer cells
(NK cells) and cytotoxic
T cells. “Before any organ damage can happen, T cells have to produce granzyme
B, which is why this is an early detection method,” said Gabe Kwong, PhD, Assistant
Professor in the Wallace H. Coulter Department of Biomedical Engineering at
Georgia Tech and Emory University, in the news release.
The new technology is made up of sensor nanoparticles in the
shape of a ball with iron oxide in the middle. Amino acids stick out of the
ball like bristles. Each amino acid has a fluorescent molecule attached to the
tip.
The nanoparticles are injected into the patient. Their size
prevents them from gathering in the patient’s tissue or from being flushed out
through the kidneys. They are designed to accumulate in the tissue of the
transplanted organ.
If the T cells in the transplanted organ begin to produce
granzyme B, the amino acids break away from the nanoparticles, releasing the
fluorescent molecules attached to their tips. Those molecules are small enough
to be processed through the kidneys and can be detected in the patient’s urine.
Pathologists Play Crucial Role on Transplant Teams
Anatomical pathologists (histopathologists in the UK) are key
members of transplant teams for many reasons, including their ability to assess
biopsies. The current method for detecting organ transplant rejection involves
needle biopsies. It is considered the gold standard.
However, according to a paper published in the International
Journal of Organ Transplantation Medicine: “Although imaging studies
and laboratory findings are important and helpful in monitoring of the
transplanted liver, in many circumstances they are not sensitive enough. For
conditions such as rejection of the transplant, liver histology remains the
gold-standard test for the diagnosis of allograft dysfunction. Therefore,
histopathologic assessments of allograft liver
biopsies have an important role in managing patients who have undergone liver
transplantation.”
There are two main problems with needle biopsies. The first,
as mentioned above, is that they don’t always catch the rejection soon enough.
The second is that the needle may cause damage to the transplanted organ.
“The biggest risk of a biopsy is bleeding and injury to the transplanted organ,” noted Andrew Adams, MD, PhD (above), Co-Principal Investigator and an Associate Professor of Surgery at Emory University School of Medicine, in the Georgia Tech news release. “Then there’s the possibility of infection. You’re also just taking a tiny fraction of the transplanted organ to determine what’s going on with the whole organ, and you may miss rejection or misdiagnose it because the needle didn’t hit the right spot,” he added.
And, according to Kwong, even though biopsies are the gold
standard, the results represent one moment in time. “The biopsy is not
predictive. It’s a static snapshot. It’s like looking at a photo of people in
mid-jump. You don’t know if they’re on their way up or on their way down. With
a biopsy, you don’t know whether rejection is progressing or regressing.”
Future Directions of Emory’s Research
The research conducted by Adams and Kwong, et al, is in its
early stages, and the new technology they created won’t be ready to be used on patients
for some time. Nevertheless, there’s reason to be excited.
Nanoparticles are not nearly as invasive as a needle biopsy.
Thus, risk of infection or damaging the transplanted organ is much lower. And Emory’s
technology would allow for much earlier detection, as well as giving clinicians
a better way to adjust the dose of immunosuppressant drugs the patient takes.
“Adjusting the dose is very difficult but very important
because heavy immunosuppression increases occurrence of infections and patients
who receive it also get cancer more often,” said Kwong. The new technology
provides a method of measuring biological activity rates, which would give
clinicians a clearer picture of what’s happening.
The Emory team’s plan is to enhance the new sensors to
detect at least one other major cause of transplant rejection—antibodies. When
a patient’s body rejects a transplanted organ, it produces antibodies to
neutralize what it sees as a foreign entity.
“Antibodies kill their target cells through similar types of
enzymes. In the future, we envision a single sensor to detect both types of
rejection,” said Kwong.
Adams adds, “This method could be adapted to tease out
multiple problems like rejection, infection, or injury to the transplanted
organ. The treatments for all of those are different, so we could select the
proper treatment or combination of treatments and also use the test to measure
how effective treatment is.”
This line of research at Emory University demonstrates how
expanding knowledge in a variety of fields can be combined in new ways. As this
happens, medical laboratories not only get new biomarkers that can be
clinically useful without the need for invasive procedures like needle biopsies,
but these same biomarkers can guide the selection of more effective therapies.
Cerner and Epic are the industry’s revenue leaders, though smaller vendors remain popular with physician groups
Sales of electronic health record (EHR) systems and related hardware and services reached $31.5 billion in 2018. And those sales will increase, according to a 2019 market analysis from Kalorama Information. This is important information for clinical laboratories and anatomic pathology groups that must interface with the EHRs of their physician clients to enable electronic transmission of lab orders and test results between doctor and lab.
Kalorama’s ranking includes familiar big EHR manufacturer names—Cerner (NASDAQ:CERN) and Epic—and includes a new name, Change Healthcare, which was born out of Change Healthcare Holding’s merger with McKesson. However, smaller EHR vendors remain popular with many independent physicians.
“We estimate that 40% of the market is not in the top 15 [in total revenue rankings],” said Bruce Carlson, Kalorama’s publisher, in an exclusive interview with Dark Daily. “There’s a lot of room. There are small vendors out there—Amazing Charts, e-MDs, Greenway, NextGen, Athena Health—that show up on a lot of physician surveys.”
“The EHR is really important,” noted Bruce Carlson (above), Publisher at Kalorama. “Since there are a variety of systems—sometimes different from the LIS [laboratory information management system]—you want to make sure you know the vendors and the space.” Carlson says opportunities remain for new entrants in the 700-plus competitor space, which is expected to see continued mergers and acquisitions that will affect clinical laboratories and their client physicians. (Photo copyright: Twitter.)
Interoperability a Key Challenge, as Most Medical
Laboratories Know
Interoperability—or the lack thereof—remains one of the
industry’s biggest challenges. For pathologists, that means seamless electronic
communication between medical laboratories and provider hospitals can be
elusive and can create a backlash against EHR vendors.
Kalorama notes a joint investigation by Fortune and Kaiser Health News (KHN), titled, “Death by a Thousand Clicks: Where Electronic Health Records Went Wrong.” The report details the growing number of medical errors tied to EHRs. One instance involved a California lawyer with herpes encephalitis who allegedly suffered irreversible brain damage due to a treatment delay caused by the failure of a critical lab test order to reach the hospital laboratory. The order was typed into the EHR, but the hospital’s software did not fully interface with the clinical laboratory’s software, so the lab did not receive the order.
“Many software vendors and LIS systems were in use prior to
the real launching of EHRs—the [federal government] stimulus programs,” Carlson
told Dark Daily. “There are a lot of legacy systems that aren’t
compatible and don’t feed right into the EHR. It’s a work in progress.”
Though true interoperability isn’t on the immediate horizon, Carlson expects its arrival within the next five years as the U.S. Department of Health and Human Services ramps up pressure on vendors.
“I think it is going to be a simple matter eventually,” he
said. “There’s going to be much more pressure from the federal government on
this. They want patients to have access to their medical records. They want one
record. That’s not going to happen without interoperability.”
Other common criticisms of EHRs include:
Wasted provider time: a recent study published in JAMA Internal Medicine notes providers now spend more time in indirect patient care than interacting with patients.
Physician burnout: EHRs have been shown to increase physician stress and burnout.
Not worth the trouble: The debate continues over whether EHRs are improving the quality of care.
Negative patient outcomes: Fortune’s investigation outlines patient safety risks tied to software glitches, user errors, or other flaws.
There’s No Going Back
Regardless of the challenges—and potential dangers—it appears EHRs are here to stay. “Any vendor resistance of a spirited nature is gone. Everyone is part of the CommonWell Health Alliance now,” noted Carlson.
Clinical laboratories and pathology groups should expect
hospitals and health networks to continue moving forward with expansion of
their EHRs and LIS integrations.
“Despite the intensity of attacks on EHRs, very few health systems are going back to paper,” Carlson said in a news release. “Hospital EHR systems are largely in place, and upgrades, consulting, and vendor switches will fuel the market.”
Thus, it behooves clinical laboratory managers and
stakeholders to anticipate increased demand for interfaces to hospital-based
healthcare providers, and even off-site medical settings, such as urgent care
centers and retail health clinics.
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.
“Viruses are these tiny things that you can’t even see, but because they’re present in such huge numbers, they really matter,” Matthew Sullivan, PhD, a microbiologist at Ohio State University and one of the study’s authors, said in a new release. “We’ve developed a distribution map that is foundational for anyone who wants to study how viruses manipulate the ecosystem. There were many things that surprised us about our findings.” These new discoveries could someday form the basis for new medical laboratory tests and therapeutic drugs. (Photo copyright: Ohio State University.)
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.
