News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Woman Performs Do-it-yourself Fecal Transplant to Relieve Symptoms of IBS, Gets Donor’s Acne

Clinical laboratory scientists and microbiologists could play a role in helping doctors explain to patients the potential dangers of do-it-yourself medical treatments

Be careful what you wish for when you perform do-it-yourself (DIY) medical treatments. That’s the lesson learned by a woman who was seeking relief for irritable bowel syndrome (IBS). When college student Daniell Koepke did her own fecal transplant using poop from her brother and her boyfriend as donors her IBS symptoms improved, but she began to experience medical conditions that afflicted both fecal donors.

“It’s possible that the bacteria in the stool can influence inflammation in the recipient’s body, by affecting their metabolism and activating their immune response,” microbial ecologist Jack Gilbert, PhD, Professor and Associate Vice Chancellor at University of California San Diego (UC San Diego) told Business Insider. “This would cause shifts in their hormonal activity, which could promote the bacteria that can cause acne on the skin. We nearly all have this bacterium on skin, but it is often dormant,” he added.

A Fecal Microbiota Transplant (FMT) is a procedure where stool from a healthy donor is transplanted into the microbiome of a patient plagued by a certain medical condition.

Our guts are home to trillions of microorganisms (aka, microbes), known as the gut microbiota, that serve many important functions in the body. The microbiome is a delicate ecosystem which can be pushed out of balance when advantageous microbes are outnumbered by unfavorable ones. An FMT is an uncomplicated and powerful method of repopulating the microbiome with beneficial microbes.   

“With fecal microbiome transplants there is really compelling evidence, but the science is still developing. We’re still working on if it actually has benefits for wider populations and if the benefit is long-lasting,” said Gilbert in a Netflix documentary titled, “Hack Your Health: The Secrets of Your Gut.”

“The microbial community inside our gut can have surprising influences on different parts of our body,” microbial ecologist Jack Gilbert, PhD (above), of the Gilbert Lab at University of California San Diego told Business Insider. “Stools are screened before clinical FMTs, and anything that could cause major problems, such as certain pathogens, would be detected. When you do this at home, you don’t get that kind of screening.” Doctors and clinical laboratories screening patients for IBS understand the dangers of DIY medical treatments. (Photo copyright: University of California San Diego.)

Changing Poop Donors

When Koepke began experiencing symptoms of IBS including indigestion, stabbing pains from trapped gas and severe constipation, she initially turned to physicians for help.

In the Netflix documentary, Koepke stated that she was being prescribed antibiotics “like candy.” Over the course of five years, she completed six rounds of antibiotics per year, but to no avail.

She also changed her diet, removing foods that were making her symptoms worse. This caused her to lose weight and she eventually reached a point where she could only eat 10 to 15 foods. 

“It’s really hard for me to remember what it was like to eat food before it became associated with anxiety and pain and discomfort,” she said.

In an attempt to relieve her IBS symptoms, Koepke made her own homemade fecal transplant pills using donated stool from her brother. After taking them her IBS symptoms subsided and she slowly gained weight. But she developed hormonal acne just like her brother. 

Koepke then changed donors, using her boyfriend’s poop to make new fecal transplant pills. After she took the new pills, her acne dissipated but she developed depression, just like her boyfriend. 

“Over time, I realized my depression was worse than it’s ever been in my life,” Koepke stated in the documentary.

She believes the microbes that were contributing to her boyfriend’s depression were also transplanted into her via the fecal transplant pills. When she reverted to using her brother’s poop, her depression abated within a week.

Gilbert told Business Insider his research illustrates that people who suffer from depression are lacking certain bacteria in their gut microbiome.

“She may have had the ‘anti-depressant’ bacteria in her gut, but when she swapped her microbiome with his, her anti-depressant bacteria got wiped out,” he said.

FDA Approves FMT Therapy for Certain Conditions

Typically, the fecal material for an FMT procedure performed by a doctor comes from fecal donors who have been rigorously screened for infections and diseases. The donations are mixed with a sterile saline solution and filtered which produces a liquid solution. That solution is then administered to a recipient or frozen for later use. 

Fecal transplant methods include:

On November 30, 2022, the US Food and Drug Administration (FDA) approved the first FMT therapy, called Rebyota, for the prevention of Clostridioides difficile (C. diff.) in adults whose symptoms do not respond to antibiotic therapies. Rebyota is a single-dose treatment that is administered rectally into the gut microbiome at a doctor’s office. 

Then, in April of 2023, the FDA approved the use of a medicine called Vowst, which is the first oral FMT approved by the FDA.

According to the Cleveland Clinic, scientists are exploring the possibility that fecal transplants may be used as a possible treatment for many health conditions, including:

Doctors and clinical laboratories know that do-it-yourself medicine is typically not a good idea for obvious reasons. Patients seldom appreciate all the implications of the symptoms of an illness, nor do they fully understand the potentially dangerous consequences of self-treatment. Scientists are still researching the benefits of fecal microbiota transplants and hope to discover more uses for this treatment. 

—JP Schlingman

Related Information:

A Woman Gave Herself Poop Transplants Using Her Brother’s Feces to Treat Debilitating IBS. Then She Started Getting Acne Just Like Him.

FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides Difficile Infection

FDA Approves First FMT Therapy and Issues Guidance

Everything You Want to Know about Irritable Bowel Syndrome (IBS)

Stanford University Scientists Discover New Lifeform Residing in Human Microbiome

Microbiome Firm Raises $86.5 Million and Inks Deal to Sell Consumer Test Kits in 200 CVS Pharmacies

Researchers Find Health of Human Microbiome Greatly Influenced by Foods We Eat

US Hospitals Continue to Be Squeezed by Shortage of Nurses, Rising Salaries

It is more than a shortage of nurses, as most clinical laboratories report the same shortages of medical technologists and increased labor costs

Just as hospital-based clinical laboratories are unable to hire and retain adequate numbers of medical technologists (MTs) and clinical laboratory scientists (CLSs), the nursing shortage is also acute. Compounding the challenge of staffing nurses is the rapid rise in the salaries of nurses because hospitals need nurses to keep their emergency departments, operating rooms, and other services open and treating patients while also generating revenue.

The nursing shortage has been blamed on burnout due to the COVID-19 pandemic, but nurses also report consistently deteriorating conditions and say they feel undervalued and under-appreciated, according to Michigan Advance, which recently covered an averted strike by nurses at 118-bed acute care McLaren Central Hospital in Mt. Pleasant and 97-bed teaching hospital MyMichigan Medical Center Alma, both in Central Michigan.

“Nurses are leaving the bedside because the conditions that hospital corporations are creating are unbearable. The more nurses leave, the worse it becomes. This was a problem before the pandemic, and the situation has only deteriorated over the last three years,” said Jamie Brown, RN, President of the Michigan Nurses Association (MNA) and a critical care nurse at Ascension Borgess Hospital in Kalamazoo, Michigan Advance reported.

Jamie Brown, RN

“The staffing crisis will never be adequately addressed until working conditions at hospitals are improved,” said Jamie Brown, RN (above), President of the Michigan Nurses Association in a press release. Brown’s statement correlates with claims by laboratory technicians about working conditions in clinical laboratories all over the country that are experiencing similar shortages of critical staff. (Photo copyright: Michigan Nurses Association.)

Nurse Understaffing Dangerous to Patients

In the lead up to the Michigan nurses’ strike, NPR reported on a poll conducted by market research firm Emma White Research LLC on behalf of the MNA that found 42% of nurses surveyed claimed “they know of a patient death due to nurses being assigned too many patients.” The same poll in 2016 found only 22% of nurses making the same claim.

And yet, according to an MNA news release, “There is no law that sets safe RN-to-patient ratios in hospitals, leading to RNs having too many patients at one time too often. This puts patients in danger and drives nurses out of the profession.”

Other survey findings noted in the Emma White Research memo to NPR include:

  • Seven in 10 RNs working in direct care say they are assigned an unsafe patient load in half or more of their shifts.
  • Over nine in 10 RNs say requiring nurses to care for too many patients at once is affecting the quality of patient care.
  • Requiring set nurse-to-patient ratios could also make a difference in retention and in returning qualified nurses to the field.

According to NPR, “Nurses across the state say dangerous levels of understaffing are becoming the norm, even though hospitals are no longer overwhelmed by COVID-19 patients.”

Thus, nursing organizations in Michigan, and the legislators who support change, have proposed the Safe Patient Care Act which sets out to “to increase patient safety in Michigan hospitals by establishing minimum nurse staffing levels, limiting mandatory overtime for RNs, and adding transparency,” according to an MNA news release.

Huge Increase in Nursing Costs

Another pressure on hospitals is the rise in the cost of replacing nurses with temporary or travel nurses to maintain adequate staffing levels.

In “Hospital Temporary Labor Costs: a Staggering $1.52 Billion in FY2022,” the Massachusetts Health and Hospital Association noted that “To fill gaps in staffing, hospitals hire registered nurses and other staff through ‘traveler’ agencies. Traveler workers, especially RNs in high demand, command higher hourly wages—at least two or three times more than what an on-staff clinician would earn. Many often receive signing bonuses. In Fiscal Year 2019, [Massachusetts] hospitals spent $204 million on temporary staff. In FY2022, they spent $1.52 billion—a 610% increase. According to the MHA survey, approximately 77% of the $1.52 billion went to hiring temporary RNs.”

It’s likely this same scenario is playing out in hospitals all across America.

Are Nursing Strikes a Symptom of a Larger Healthcare Problem?

In “Nurses on Strike Are Just the Tip of the Iceberg. The Care Worker Shortage Is About to Touch Every Corner of the US Economy,” Fortune reported that nationally the US is facing a shortage of more than 200,000 nurses.

“But the problem is much bigger,” Fortune wrote. “Care workers—physicians, home health aides, early childhood care workers, physician assistants, and more—face critical challenges as a result of America’s immense care gap that may soon touch every corner of the American economy.”

Clinical laboratories are experiencing the same shortages of critical staff due in large part to the same workplace issues affecting nurses. Dark Daily covered this growing crisis in several ebriefings.

In “Forbes Senior Contributor Covers Reasons for Growing Staff Shortages at Medical Laboratories and Possible Solutions,” we covered an article written by infectious disease expert Judy Stone, MD, in which she noted that factors contributing to the shortage of medical technologists and other clinical laboratory scientists include limited training programs in clinical laboratory science, pay disparity, and staff retention.

We also covered in that ebrief how the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to the nation’s network of clinical laboratories.

And in “Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic,” we reported on the personal story of Suzanna Bator, a former laboratory technician with the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio. Bator shared her experiences in an essay for Daily Nurse that took a personalized, human look at the strain clinical laboratory technicians were put under during the SARS-CoV-2 pandemic. Her story presents the quandary of how to keep these critical frontline healthcare workers from experiencing burnout and leaving the field.

Did Experts See the Shortages Coming?

Hospitals across the United States—and in the UK, according to Reuters—are facing worker strikes, staff shortages, rising costs, and uncertainty about the future. Just like clinical laboratories and other segments of the healthcare industry, worker burnout and exhaustion in the wake of the COVID-19 pandemic are being cited as culprits for these woes.

But was it predictable and could it have been avoided?

“One of the big things to clear up for the public is that … we saw the writing on the wall that vacancies were going to be a problem for us, before the pandemic hit our shores,” Christopher Friese, PhD, professor of Nursing and Health Management Policy at the University of Michigan (UM), told NPR. Friese is also Director of the Center for Improving Patient and Population Health at UM.

Effects of the COVID-19 pandemic, and staffing shortages exasperated by it, will be felt by clinical laboratories, pathology groups, and the healthcare industry in general for years to come. Creative solutions must be employed to avoid more staff shortages and increase employee retention and recruitment.

Ashley Croce

Related Information:

Amid Burnout and Exhaustion, Nurses at Two Mid-Michigan Hospitals OK New Contracts

‘Everyone Is Exhausted and Burned Out’: McLaren Central Nurses Authorize Potential Strike

New Poll Shows a Nurse-to-Patient Ratio Law Could Be Key to Addressing Staffing Crisis

42% of Michigan Nurses Say High Patient Load Led to Deaths

Michigan Nurses Report More Patients Dying Due to Understaffing, Poll Finds

COVID-19’s Impact on Nursing Shortages, the Rise of Travel Nurses, and Price Gouging

Survey of Registered Nurses Living or Working in Michigan

This Nursing Shortage Requires Innovative Solutions

Nurses on Strike Are Just the Tip of the iceberg. The Care Worker Shortage Is About to Touch Every Corner of the US Economy

Workers Stage Largest Strike in History of Britain’s Health Service

Nursing Shortage by State: Which US States Need Nurses the Most and Which Ones Will Have Too Many?

Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic

It’s not only medical laboratory technicians, healthcare workers across the board continue to deal with extreme pressures that preceded the pandemic

Burnout in healthcare is a constant problem, especially in overstressed clinical laboratories and anatomic pathology groups. To raise awareness about the plight of medical laboratory technicians (MLTs) and other frontline workers in the healthcare industry, a former lab tech recounted her experience during the COVID-19 pandemic that led to burnout and her departure from the lab profession during 2020-2021.

Suzanna Bator was formerly a laboratory technician with the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio. Her essay in Daily Nurse, titled, “The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic,” is a personalized, human look at the strain clinical laboratory technicians were put under during the pandemic. Her story presents the quandary of how to keep these critical frontline healthcare workers from experiencing burnout and leaving the field.

“We techs were left unsupported and unmentored throughout the pandemic. No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention,” she wrote.

Clinical laboratory leaders and pathology group managers may find valuable insights in Bator’s essay that they can use when developing worker support programs for their own clinical laboratories and practices.

Suzanna Bator

“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” Suzanna Bator wrote in Daily Nurse. Burnout in clinical laboratories is an ongoing problem that increased during the COVID-19 pandemic. (Photo copyright: Daily Nurse.)

Hopeful Beginnings and Eager to Help

During the early days of the COVID-19 pandemic, folks in every industry stepped up. Fashion designers tasked their haute couture seamstresses with making personal protective equipment (PPE), neighbors brought food and supplies to their immunosuppressed or elderly neighbors, and healthcare workers took on enormous workloads outside of their own departments and traditional responsibilities, The New York Times reported.

When Bator joined the Cleveland Clinic’s COVID-19 team she had no clinical lab tech accreditations. Nevertheless, she and 12 other non-accredited hires were quickly put onto the second and third shifts to keep up with SARS-CoV-2 test demands.

“In the beginning, I was so happy to be helping and working during the pandemic. I felt proud to be on the front lines, honing my skills and discovering what it was like to work under intense pressure. My work was good even when the work was hard. There was no room for error and no time to waste.”

At the Cleveland Clinic, Bator and her colleagues did not experience the equipment and supply shortages other clinics faced, at least not in the beginning of the pandemic. That began to change in late 2020.

Unrelenting Pace and Supply Shortages as Pandemic Grew

Despite their state-of-the-art equipment at the Cleveland Clinic, problems began to arise as the pandemic wore on.

“The machines we worked on were never meant to be run at this intensity and would frequently break down during the second shift. Those of us on the third shift were then left to deal with these problems despite our lack of technical training. Even worse, there were no supervisors on staff to help us problem-solve or troubleshoot, which only added to the pressure,” Bator noted.

And the high demand for testing left little room for new lab techs to hone any other skills.

“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” she added.

Eventually, Bator left the Cleveland Clinic for a county hospital to “get off the graveyard shift and begin working on more than just COVID testing,” she wrote. However, soon after her move the Omicron variant hit, and she was once again running COVID tests.

Six months later she had had enough. She burned out and “dropped out of the industry after only a few years,” she wrote. And she was not the only one.

“The [Cleveland] Clinic began to hemorrhage techs who left for better opportunities at different hospitals or in different fields. Of my original 15-or-so-member team two years ago, only four remain in the same department, and only about half remain in the clinical lab field at all,” Bator wrote.

Burnout in Clinical Laboratories

Worker burnout is a state of mental and/or physical exhaustion caused by a heavy workload. Those experiencing burnout may feel emotionally overwhelmed, anxious, and depressed. Burnout can manifest in physical, mental, and emotional symptoms.

Burnout in the wake of the COVID-19 pandemic is an issue affecting all facets of healthcare. According to Forbes, a 2022 report by Elsevier Health found that 47% of US healthcare workers plan to leave their current role in the next two to three years, in some measure due to the enormous pressures healthcare workers face.

And workers are not the only ones paying attention to burnout. On May 23, 2022, the United States Surgeon General, Vice Admiral Vivek Murthy, MD, issued a Surgeon General’s Advisory highlighting the need to address worker burnout.

“COVID-19 has been a uniquely traumatic experience for the health workforce and for their families, pushing them past their breaking point,” Murthy noted. “Now, we owe them a debt of gratitude and action. And if we fail to act, we will place our nation’s health at risk. This Surgeon General’s Advisory outlines how we can all help heal those who have sacrificed so much to help us heal.”  

Healthcare workers were facing high levels of burnout before 2020, the COVID-19 pandemic only made the issue worse. The National Academies of Medicine (NAM) reported in 2019 that worker burnout had reached a “crisis level,” and that during the pandemic, half of all healthcare workers reported symptoms of at least one mental health condition.

Training Programs Needed to Offset Worker Shortages and Retain Staff

As Bator reported in Daily Nurse, “The American Society of Clinical Pathology (ASCP)—the largest association for [medical] laboratory professionals—has stressed the importance of promoting MLS/MLT programs to produce certified, well-trained lab professionals, to fill major staffing shortages. However, filling the positions is only one piece of the puzzle.”

Bator points out that there wasn’t space nor time for guidance or advancement with the sheer volume of SARS-CoV-2 testing they had to complete.

“Late last year, during the worst of the Omicron variant surge, the only people I could commiserate with were the nurses who thanked us for running their pediatric ICU tests first,” she said. “They understood what we meant when we said we were drowning and stopped calling the lab to pester us for results because they knew that the positivity rate in Cuyahoga County was the third highest in the country and that the entire system was overwhelmed.”

Suzanna Bator is just one early-career worker among many healthcare professionals who have experienced this type of burnout due to the COVID-19 pandemic. As made evident by her piece, the pathology and clinical laboratory professions are losing workers who otherwise might have entered training programs to further their careers in those fields.

The issue of worker burnout is not just a temporary stressor on the clinical laboratory industry. Both worker burnout and staffing shortages in labs preceded the pandemic and will have continuing long-term effects unless steps are taken to reverse it.   

Ashley Croce

Related Information:

The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic

Burnout: Symptoms and Signs

Christian Siriano and Dov Charney Are Making Masks and Medical Supplies Now

Clinician of the Future Report 2022

New Survey Shows That Up to 47% of US Healthcare Workers Plan to Leave Their Positions by 2025

Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being

New Surgeon General Advisory Sounds Alarm on Health Worker Burnout and Resignation

Disgraced Theranos Founder Elizabeth Holmes to Serve 11 Years, Three Months in Prison, Ending the Latest Chapter in the Story of the Failed Clinical Laboratory Company

Judge will decide the restitution Holmes must pay to defrauded Theranos investors at future court date; Ex-COO Ramesh “Sunny” Balwani to be sentenced next month

Clinical laboratory leaders and anatomic pathologists who closely followed the fraud trial of Elizabeth Holmes may have wondered how the Theranos founder and ex-CEO would be punished for her crimes. Now we know.

On Friday, a federal court judge sentenced Holmes to 135 months—11.25 years—in prison in the culmination of her conviction on three felony counts of wire fraud and one count of conspiracy, according to NBC Bay Area News.

Late into the four-hour sentencing hearing, Holmes tearfully spoke, according to a twitter post by NBC reporter Scott Budman, who was in the courtroom. “I am devastated by my failings,” Holmes said. “I have felt deep pain for what people went through because I have failed them … To investors, patients, I am sorry.”

Davila ordered Holmes to surrender to authorities on April 27 to begin her time behind bars. She is free until that time. Her upcoming prison term caps off one of the biggest downfalls ever of an American entrepreneur.

[We first published this article in our Dark Daily E-Briefings newsletter. Sign up for free here to stay informed on the lab industry’s most important news and events.]

Elizabeth Holmes

Elizabeth Holmes (above), founder and former CEO of Theranos, the now defunct clinical laboratory company, as she enters the federal courthouse in San Jose, Calif., prior to her sentencing on Friday. In January, Holmes was convicted on three counts of wire fraud and one count of conspiracy. Last summer, Theranos’ former CLIA laboratory director, pathologist Adam Rosendorff, MD, expressed remorse over his testimony which led to Holmes’ defense team requesting a new trial. The judge denied that request and allowed the sentencing of Holmes to proceed as scheduled. (Photo copyright: Jim Wilson/The New York Times.)

.

Defense Lawyers Plan to Appeal

Dean Johnson, JD, a California criminal defense lawyer, told NBC Bay Area News during live coverage of the hearing on Friday that Holmes’ defense team will appeal her conviction.

“I have no doubt there will be an appeal in this case,” Johnson said.

Judge Edward Davila, who oversaw Holmes’ trial and sentencing hearing in US District Court in San Jose, Calif., estimated that the total loss for Theranos investors was $121 million. Investors had committed funds to support the company’s flawed Edison blood testing technology. A separate restitution hearing for Holmes will be scheduled for a later date.

Beyond the sentencing, Holmes, 38, will be saddled by infamy for the rest of her life, with her past reputation as a charismatic innovator ruined.

In “Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations,” we covered how a jury convicted Holmes in January on four charges of investor and wire fraud after a four-month trial. She faced up to 20 years in prison on each of those counts.

Another Theranos executive, former Chief Operating Officer and President Ramesh “Sunny” Balwani, faces sentencing on Dec. 7. A jury found Balwani guilty of two counts of conspiracy and 10 counts of wire fraud in July.

“The judge [said] evidence shows Elizabeth Holmes was leader of the company, but not necessarily the leader of the criminal acts,” Budman tweeted. Those words clearly pointed to Balwani, who Holmes’ defense team had painted as exerting control over her and the company.

Prosecutors Sought a Stiffer Sentence for Holmes

Prosecutors had asked Davila to sentence Holmes to 15 years in prison, arguing that her conviction represented “one of the most substantial white collar offenses Silicon Valley or any other district has seen,” according to NBC Bay Area News, which cited court documents. The government also wanted her to pay $803 million in restitution.

Holmes’ defense team, however, wished for no prison time at all, instead asking that Holmes serve time under house arrest. “If a period of confinement is necessary, the defense suggests that a term of 18 months or less, with a subsequent supervised release period that requires community service, will amply meet that charge,” her lawyers wrote in a court filing.

Prior to the sentencing, Davila received 130 letters supporting Holmes and asking for leniency, NPR reported. Among them was a note from William “Billy” Evans, Holmes’ partner.

“If you are to know Liz, it is to know that she is honest, humble, selfless, and kind beyond what most people have ever experienced,” Evans wrote, NPR reported. “Please let her be free.”

Holmes and Evans have a 16-month-old son together, and she is pregnant with the couple’s second child. Her first pregnancy caused her trial to be rescheduled. Prior to last week’s sentencing, some reporters covering the trial speculated that because Holmes was the mother of an infant—and now pregnant again—the judge might be more lenient in sentencing. The 11-year, four-month sentence indicates that the judge was not much influenced by that factor.

Last Minute Pitch for New Trial Failed

Holmes’ legal wranglings continued until the very end.

On Nov. 7, Davila denied her motion for a new trial. Holmes’ lawyers had argued that key prosecution witness Adam Rosendorff, MD—a pathologist who was former laboratory director at the company—expressed remorse about his own 2021 testimony during an attempt to visit Holmes’ residence on August 2022. Dark Daily covered this event in “Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial.”

However, Rosendorff later told the court that he stood by his testimony about problems with Theranos’ blood testing technology.

In denying the request for a new trial, Davila wrote, “The court finds Dr. Rosendorff’s statements under oath to be credible,” according to The Washington Post.

From Teen Founder to Disgraced Entrepreneur

Holmes founded Theranos in 2003 at age 19 while she was attending Stanford University as a chemical engineering major. She dropped out of Stanford as a sophomore to focus on her new company.

Theranos claimed its technology—known as Edison—could perform diagnostics tests using a finger prick and a micro-specimen vial instead of a needle and several Vacutainers of blood. The company said it could return results to patients and clinicians in four hours for about half of the cost of typical lab test fees.

However, the promise of this technology began to unravel in 2015 following an investigative article by The Wall Street Journal that revealed the company ran only a handful of tests using its technology, instead relying on traditional testing for most of its specimen work.

Following The Journal’s exposé, the Centers for Medicare and Medicaid Services (CMS) sanctioned Theranos and Holmes in 2016. Meanwhile, the US Securities and Exchange Commission (SEC) investigated Holmes for raising hundreds of millions from investors by exaggerating or making false statements about the company’s technology and financial performance.

In 2018, the US Department of Justice (DOJ) indicted Holmes and Balwani, and Theranos closed shortly after.

Convictions Validated Pathologists’, Hospital Lab Leaders’ Concerns

Fortunately, the Theranos saga has not stunted investment in healthcare technology startups. Spending was in the tens of billions in 2021, although that number has dropped this year as the COVID-19 pandemic has waned, according to TechCrunch. Nevertheless, it is safe to assume that healthcare tech investors are scrutinizing scientific data from startups more thoroughly because of the Theranos fraud case.

Meanwhile, the saga of Theranos continues to leave a bad taste in the mouths of many clinical laboratory managers and pathologists. That’s because, during the peak period of adulation and spectacular news coverage about Elizabeth Holmes and her plans to totally disrupt the clinical laboratory industry, hospital and health system CEOs believed that they would be able to downsize their in-house medical laboratories and obtain lab tests from Theranos at savings of 50% or more. Consequently, during the years 2013 through the end of 2015, some hospital lab leaders saw requests for capital investment in their labs denied or delayed.

One example of how hospital CEOs embraced news of Theranos’ blood testing technology took place at the Cleveland Clinic. Elizabeth Holmes did such a good job selling the benefits of the Edison technology, then-CEO, Toby Cosgrove, MD, placed Theranos at number three on its list of top ten medical innovations for 2015.

In later years, Cosgrove admitted that no one at Cleveland Clinic or its pathologists were allowed to examine the analyzers and evaluate the technology.

It was for these reasons that the demise of Theranos was welcomed by many hospital lab administrators and pathologists. The fact that two of Theranos’ senior executives have been convicted of fraud validates many of the serious concerns that medical laboratory professionals had at that time, but which most major news reporters and media ignored and failed to report to the public.

Scott Wallask

Related Information:

Theranos Founder Elizabeth Holmes Sentenced to More than 11 Years in Prison

Elizabeth Holmes Is Sentenced to More than 11 Years for Fraud

Theranos Ex-CEO Elizabeth Holmes Convicted on Three Counts of Wire Fraud and One Count of Conspiracy to Commit Fraud after Seven Days of Jury Deliberations

Prosecutors Push 15-year Sentence for Theranos’ CEO Holmes

Elizabeth Holmes Sentenced to 11 Years in Prison for Theranos Fraud

Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Bid for New Trial Fails, Elizabeth Holmes Awaits Sentencing

Ramesh “Sunny” Balwani Convicted by a Jury on 12 Counts of Fraud in Theranos Trial

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories

Several young companies hope to expand the direct-to-consumer test market by introducing new diagnostic tests to serve the women’s health market

Providing women with at-home lab test kits is the goal of a growing class of start-up companies that are bringing to market consumer test kits for a range of health conditions common to women. These companies believe they can shift a substantial volume of such testing away from the nation’s medical laboratories.

Moreover, diagnostic startups that develop at-home direct-to-consumer (DTC) clinical laboratory genetic tests have been hot commodities among venture capitalists and other healthcare investors willing to put tens of millions of dollars into these new firms. The New York Times observed that, until recently, women’s healthcare needs have rarely been the focus of new diagnostic testing companies, but that the situation may be changing.

Femtech” (short for female technology) products and services that address the health and wellness needs of women is the new buzz word in healthcare. It describes female-focused diagnostic startups aiming at vaginal health and other medical issues that go beyond reproductive health concerns.

This, however, is a dual-edged sword for clinical laboratory leaders. Growth in this segment could lead to new diagnostics tests that boost a medical lab’s bottom line or, conversely, it could reduce revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.

Michelle Tempest, MD

“The market potential is huge,” Michelle Tempest, MD (above), a partner at the London-based healthcare consulting firm Candesic, told The New York Times. “There’s definitely an increasing appetite for anything in the world which is technology and a realization that female consumer power has arrived—and that it’s arrived in healthcare.” Tempest maintains the women’s health marketplace is ripe for growth, which could mean a boon for clinical laboratory testing and diagnostics designed specifically for women. (Photo copyright: Candesic.)

Vaginal Microbiome At-home Clinical Laboratory Tests in High Demand

One area in particular drawing the attention of several female-led startups is vaginal health. According to an article in Vogue, test developers Juno Bio and Evvy are leading the way with at-home vaginal microbiome tests that let users “know what’s up down there.”

New York City-based Evvy ($129 for a single test or $99 each for four tests per year) uses metagenomic sequencing to identify the bacteria and fungi present in the vaginal microbiome. This information helps customers to understand their levels of protective and disruptive bacteria, which can be associated with everything from reoccurring infections and transmission of sexually transmitted diseases to infertility.

London-based Juno Bio ($149 per test) does not disclose its testing method. It does, however, provide users with a “full vaginal microbiome profile.” The profile is accessed online within a “few days” of returning the vaginal swab sample to the company’s clinical laboratory.

Both companies note that their tests are intended to be used for wellness purposes and are not meant to diagnose or treat disease or substitute for a physician’s consultation.

Gynecologist Oluwatosin Goje, MD, MSCR, FACOG, a reproductive infectious disease specialist at Cleveland Clinic, believes the availability of at-home vaginal microbiome testing will provide valuable information to both women and their doctors.

“It’s a powerful tool because it enables us to look at the entire microbial community through metagenomics and decipher how the overall composition might be affecting symptoms and infections, as well as determine the best treatment pathway,” Goje, an Evvy Medical Advisor, told Vogue. “Understanding the complete vaginal microbiome allows us to be good antibiotic stewards and only administer antibiotics when needed. Patients can also retest remotely to understand how antibiotics and other treatments impacted their vaginal microbiome.”

Evvy, an at-home vaginal microbiome test

Evvy, which offers women an at-home vaginal microbiome test (above) that can provide insights into chronic vaginal infections and proclivity to contract sexually transmitted diseases and other women’s health issues, is one of several women-led diagnostic start-ups focused on women’s health. (Photo copyright: Evvy.)

Removing the Discomfort of Shopping for Women’s Health Products

Jamie Norwood and Cynthia Plotch, co-founders of Stix, a supplier of women’s health products and education, launched their company with a product line of at-home pregnancy and ovulation tests. They have since expanded their offerings to include urinary tract infection (UTI) and yeast infection testing and treatments.

“You can test, relieve, treat, and help prevent future infections—all from the comfort of your own home,” Norwood, told Vogue. She emphasized that this is the kind of experience healthcare consumers are demanding in today’s ever-growing direct-to-consumer clinical laboratory testing landscape. “Agonizing over confusing over-the-counter products in the drugstore aisles, or bending over backwards to pick up a prescription at the pharmacy, just isn’t cutting it for Millennial and Gen Z consumers.”

According to WebMD, yeast infections are a chronic problem for many women. While 75% of women will get at least one yeast infection in their lifetime, up to 8% get more than four a year. In addition, the federal Centers for Disease Control and Prevention (CDC) points out that bacterial vaginosis is the most common vaginal condition in females ages 15-44.

Lola Priego, is CEO and founder of blood test company Base, which sells at-home saliva and finger-prick blood tests to monitor hormone levels, vitamin levels, neurotransmitters, and blood cell markers to improve everything from sleep and diet to sex drive. She predicts direct-to-consumer testing will become as common as fitness watches.

“Eventually, at-home lab testing will be another readily-used tool, similar to your health-tracking wearables, that helps us optimize for a well-rounded healthy lifestyle in a more individualized way,” Priego told Vogue.

Femtech a ‘Significantly Underdeveloped’ Market

In its latest Analyst Note, financial data firm PitchBook maintained that the market for female health products is poised for growth. TechCrunch, which reviewed PitchBook’s analysis of female-focused health products, reported that Femtech remains a “significantly underdeveloped” slice of health-tech spending.

While women spend an estimated $500 billion annually on medical expenses, only 4% of research and development money is targeted at women’s health, PitchBook noted. In its analysis, Pitchbook predicted the global market for female-focused health products will reach $3 billion by the end of 2030. By comparison, that segment of the healthcare market totaled $820.6 million last year.

“While we still view Femtech as a niche industry, we believe secular drivers could help propel new growth opportunities in the space,” PitchBook analysts wrote. “These include the increasing representation of women in the venture-backed technology community, rising awareness and acceptance of women’s health issues, and the growing prevalence of infectious diseases among women in some countries in Africa and Asia.

“Furthermore, while the majority of Femtech products have traditionally focused on reproductive health, we believe new approaches to women’s health research will help open the door to new products and services,” they noted.

Clinical laboratory leaders will be wise to carefully watch the growth of at-home DTC tests and products targeted at female healthcare consumers since fewer trips to physicians’ offices may mean fewer test orders for local labs.

At the same time, the opportunity exists for innovative pathologists and lab managers to develop digital services that allow consumers who are self-testing to store their home-test results in the lab’s app. They can then receive relevant insights from clinical pathologists to help them fully understand the implications of the test results.

—Andrea Downing Peck

Related Information:

Vaginal Health Is Finally at the Forefront: These Are the Startups Destigmatizing UTIs and Yeast Infections

Is ‘Femtech’ the Next Big Thing in Healthcare?

Backed by $5M Led by General Catalyst, Evvy Launches a Vaginal Microbiome Test to Support Women’s Health Research

Stanford Graduates Develop At-Home Vaginal Microbiome Test for Women with Reoccurring Infections and Even Infertility

Femtech VC Space Poised for Growth

Femtech Poised for Growth Beyond Fertility

Pitchbook Analyst Note: Femtech Expected to Break New Grounds

How Three Startups Are Furthering At-Home Healthcare

;