Good behavior in federal prison by the disgraced founder of the now-defunct clinical laboratory company earned her the reduction in her original sentence of 11 years
Elizabeth Holmes, founder of failed clinical laboratory blood analysis company Theranos, continues to serve a lengthy term in prison after being convicted of multiple counts of fraud in 2022. However, now comes news that good behavior at her federal prison has shortened her sentence by nearly two years, according to NBC News.
The latest reduction took Holmes’ release from December 2032 to August 2032 in her “11-plus-year (135 month) prison sentence for wire fraud and conspiracy,” NBC reported, adding that Holmes, though Theranos, “defrauded investors out of hundreds of millions of dollars.”
Holmes entered FPC Bryan, a federal prison camp in Bryan, Texas, to begin serving her term in May 2023.
“Holmes had her sentence computation done within the first 30 days of arriving at Bryan,” Forbes reported. Given Good Conduct Time (GCT), Holmes was given 608 days off calculated from the start of her sentence. “If she were to incur a disciplinary infraction, some of those days can be taken away. Most all prisoners receive 54 days per year of GCT based on the sentence imposed,” Forbes added.
The Federal Bureau of Prisons (BOP) can additionally shave off up to a year through its Residential Drug Abuse Program (RDAP). “To qualify, the prisoner must not have a disqualifying offense, such as terrorism or gun charge, and voluntarily provided information that they had a drug or alcohol problem prior to their arrest. This disclosure has to be done prior to sentencing during the pre-sentence interview and must be also documented in the Presentence Report, a detailed report used by the BOP to determine things like classification and programming for the prisoner,” Forbes noted.
Additionally, the federal First Step Act, which President Trump signed into law in 2018, enables Holmes to “earn up to 365 days off any imposed sentence by participating in prison programming such as a self-improvement classes, a job, or religious activities,” Forbes reported.
Given the opportunities to shave time off her sentence, Holmes may ultimately serve just 66 months of her original 135 month sentence in federal prison.
Elizabeth Holmes (above) taken backstage at TechCrunch Disrupt San Francisco 2014 when Holmes was at the height of her fame and popularity. At this point, Theranos’ Edison blood testing device had not yet been shown to be a fake. But evidence was mounting as clinical laboratory scientists and anatomic pathologists became aware of the technology’s shortcomings. (Photo copyright: Max Morse/Wikimedia Commons.)
Fall of a Silicon Valley Darling
Theranos boasted breakthrough technology and became an almost overnight sensation in Silicon Valley when it burst onto the scene in 2003. Holmes, a then 19-year-old Stanford University dropout, claimed Theranos would “revolutionize the world of blood testing by reducing sample sizes to a single pin prick,” Quartz reported.
The height of the company saw Theranos valued at $9 billion, which came crashing down when the Wall Street Journal reported in 2015 that questionable accuracy and procedures were being followed by the company, CNN reported.
“From the moment Holmes concluded her presentation and stepped off the podium on Monday afternoon, she, her company, and her comments became the number one subject discussed by attendees in the halls between sessions and in the AACC exhibit hall,” Michel wrote, adding, “The executive team and the investors at Theranos have burned through their credibility with the media, the medical laboratory profession, and the public. In the future, the company’s claims will only be accepted if presented with scientific data developed according to accepted standards and reviewed by credible third parties. Much of this data also needs to be published in peer-reviewed medical journals held in highest esteem.”
Ultimately, investors who had jumped in early with financial support for Theranos were defrauded of hundreds of millions of dollars and Holmes was sentenced to 11 years/three months behind bars.
“Theranos had only ever performed roughly a dozen of the hundreds of tests it offered using its proprietary technology, and with questionable accuracy. It also came to light that Theranos was relying on third-party manufactured devices from traditional blood testing companies rather than its own technology,” CNN added.
The company shut down in 2018.
And so, the Elizabeth Holmes saga continues with reductions in her prison sentence for “good behavior.” The irony will likely not be lost on the anatomic pathologists, clinical laboratory scientists, and lab managers who followed the federal trials.
As the cancer registry expands it will increasing become more useful to anatomic pathologists, histopathologists, oncologists, and even clinical laboratories
Oncologists, histopathologists, anatomic pathologists, and other cancer physicians now have a powerful new Wikipedia-style tumor registry to help them with their diagnoses and in educating patients on their specific types of cancer. Clinical laboratory managers may find it useful to understand the value this searchable database, and it can help their staff pathologists as well.
Free to use by both physicians and patients the World Tumor Registry (WTR) is designed “to minimize diagnostic errors by giving doctors a searchable online database of cancers that have been collected and categorized with cellular images collected from around the world,” Pittsburg-Post Gazette reported.
Prompt, accurate cancer diagnoses offer cancer patients the best chance for optimal treatment outcomes. However, many medical professionals around the globe do not have the training and resources to offer superior cancer diagnoses. That deficiency can translate to inferior treatment options and lower survival rates among cancer patients.
To help improve cancer diagnoses, pathologist Yuri E. Nikiforov, MD, PhD, Division Director, Molecular and Genomic Pathology, Vice Chair of the Department of Pathology, and Professor of Pathology, University of Pittsburgh, developed the WTR to provide educational and practical resources for individuals and organizations involved in cancer research.
Officially announced at the United States and Canadian Academy of Pathology (USCAP) annual convention, the WTR is an open-access catalog of digital microscopic images of human cancer types and subtypes.
The lower cost of technology and improved speed of access via the internet are technologies enabling this effort.
“We are creating sort of a Wikipedia for cancer images,” said Alyaksandr V. Nikitski, MD, PhD (above), Research Assistant Professor of Pathology, Division of Molecular and Genomic Pathology at Pittsburg School of Medicine and Administrative Director of the WTR, in an exclusive interview with Dark Daily. “Anyone in the world, if they can access the internet, can look at the well-annotated, diagnostic digital slides of cancer,” said Nikitski. Clinical laboratories may also find this new pathology tool useful. (Photo copyright: Alyaksandr V. Nikitski)
Minimizing Diagnostic Errors
Based in Pittsburgh, the WTR is freely available to anyone for viewing digital pathology slides of known cancer tumors as well as borderline and questionable cases. On the website, individuals can search for pictures of tumors in the registry by diagnosis, specific cohorts, and by microscopic features. Individuals may search further by tumor type and subtype to receive a picture of related tumors.
According to the WTR website, the mission of the nonprofit “is to minimize diagnostic errors, eliminate inequality in cancer recognition, diagnosis, and treatment in diverse populations, and improve outcomes by increasing access to the diagnostic pathology expertise and knowledge of microscopic characteristics of cancers that occur in different geographic, environmental, and socio-economic settings.”
This new comprehensive initiative will eventually encompass cancer images from all over the world.
“Let’s assume that I am a pathologist or a trainee who has little experience, or I don’t have access to collections of atypical tumors,” Nikitski explained. “I can view tumor collections online [in the WTR database] and check how typical and rare tumors look in various geographic regions and environmental settings.”
Once an image of a slide is selected, users will then receive a brief case history of the tumor in addition to such data as the age of the patient, their geographic location, sex, family history of the disease, and the size and stage of the tumor.
Increasing Probability of Correct Diagnosis
Pathologists and clinicians may also predict the probability of a particular diagnosis by searching under the microscopic feature of the database. This feature utilizes an innovative classifier known as PathDxFinder, where users may compare a slide from their lab to slides in the database by certain criteria. This includes:
After completing the questions above, the user presses the “predict diagnosis” button to receive the probability of cancer and most likely diagnosis based on the answers provided in the questionnaire.
WTR Editorial Boards
The WTR represents collections for each type of cancer site, such as lung or breast. A chairperson and editorial board are responsible for reviewing submitted slides before they are placed online. The editorial boards include 20 pathologists who are experts in diagnosing cancer categories, Nikitski explained.
Thousands of identified microscopic whole slide images (WSI) representing various types of cancer are deposited by the editors and other contributors to the project. The editorial board then carefully analyzes and compiles the data before posting the images for public viewing.
The editorial boards are located in five world regions:
Africa and the Middle East
Asia and Oceania
Central and South America
North America and Europe
Northern Asia
Any physicians or pathologists can contribute images to the database, by “simply selecting the editor of their region on the website, writing their name, and asking if they can submit tumor cases,” Nikitski stated.
“We have established a platform that allows pathologists to contact editors who are in the same geographic region,” he added.
Helping Physicians Identify Cancer Types
In a YouTube video, Nikiforov states that the WTR is an “educational nonprofit organization rooted in [the] beliefs that every cancer patient deserves accurate and timely diagnosis as the first and essential step in better treatment and outcomes.”
“We believe this can be achieved only when modern diagnostic tools and technologies are freely available to every physician and pathologist. Only when we understand how microscopic features of cancer vary in different geographic, environmental and ethnic populations, and only by integrating histopathology with clinical immunohistochemical and molecular genetic information for every cancer type,” he stated.
Since patient privacy is important, the database contains only basic data about patients, and all patient information is protected.
Launched in March, there are currently more than 400 thyroid tumor slides available to view in the online database. At the time of the announcement, the WTR platform was planned to be implemented in three phases:
Thyroid cancer (released in March of this year).
Lung cancer and breast cancer (anticipated to be completed by the third quarter of 2026).
Remaining cancers, including brain, soft tissue and bone, colorectal, head and neck, hematolymphoid, female genital, liver, pancreatic, prostate and male genital, skin, urinary system, pediatric, other endocrine cancers, and rare cancers (anticipated to be completed by the end of 2029).
“We believe that this resource will help physicians and pathologists practicing in small or big or remote medical centers to learn how cancer looks under a microscope in their own communities,” Nikiforov said in the video. “We also see WTR as a platform that connects physicians and scientists from different parts of the world who can work together to better understand and treat cancer.”
Catalogs like the World Tumor Registry might potentially create a pool of information that that could be mined by analytical and artificial intelligence (AI) platforms to ferret out new ways to improve the diagnosis of certain types of cancer and even enable earlier diagnoses.
“It is an extremely useful resource,” Nikitski said.
Anatomic pathologists will certainly find it so. And clinical laboratory managers may find the information useful as well when interacting with histopathologists and oncologists.
Clinical studies show that new ‘cell-free’ test can predict cardiovascular disease risk better than standard HDL cholesterol test
Researchers from the National Institutes of Health (NIH) have developed a diagnostic assay that measures how well high-density lipoprotein (HDL)—the so-called “good” cholesterol—is working in the body. And their findings could lead to new clinical laboratory tests that supplement standard HDL level testing to better determine a person’s risk for heart disease.
Cholesterol tests are among the most commonly performed assays by clinical laboratories. A new test that reveals how well HDL is working in the body would certainly boost a medical laboratory’s test requisition volume.
“Measuring HDL function is limited to research labs and isn’t conducive to large-scale testing by routine clinical laboratories. To try to solve that problem, researchers from NHLBI’s Lipoprotein Metabolism Laboratory created a new diagnostic test,” noted an NHLBI news release.
“This is going to quicken the pace of basic research,” said Edward B. Neufeld, PhD, who along with guest researcher Masaki Sato, PhD, developed the test. “It increases the number of samples that you can study. It increases the number of experiments you can do.”
Such a new cholesterol test would quickly become one of the most commonly performed clinical lab tests because just about every American who has a physical gets cholesterol tests as part of that process.
“Other people may modify this or come up with better versions, which is fine with us,” Edward Neufeld, PhD (above), NHLBI Staff Scientist, said in a news release. “We just really wanted to tackle this problem of evaluating HDL function.” Clinical laboratories may soon have a new cholesterol test to supplement standard HDL level testing. (Photo copyright: ResearchGate.)
Faster Answers Needed about HDL
According to the NIH, the goal should go beyond measuring level of HDL as part of a person’s annual physical. What is also needed is finding out whether HDL cholesterol is effectively doing certain tasks, such as removing extra cholesterol from arteries and transporting it to the liver.
The NHLBI’s new cell-free test may make it possible to step up large-scale clinical testing of HDL function, according to the news release. As it stands now, HDL function study has been limited to research labs where testing involves “harvesting cells in the lab [which] can take days to process,” according to NIH Record.
“Most studies to date that have assessed CAD (coronary artery disease) risk by HDL functionality still use the CEC (cellular cholesterol efflux capacity) in vitro assay and are based on the use of radioisotopes (3H-cholesterol) and cultured cells, which is very labor intensive and impractical to do in a clinical laboratory,” the researchers wrote in The Journal of Clinical Investigation. They also pointed out that CEC batch-to-batch variability does not fit clinical laboratories’ need for standardization.
Advantages of NHLBI’s Test
To overcome these barriers, the NHLBI researchers created an HDL-specific phospholipid efflux (HDL-SPE) assay that has certain advantages over current HDL function assessments done in research labs.
According to the NIH, the HDP-SPE assay:
Is easy to replicate in clinical labs.
Is more suited to automation and large samples.
Offers up results in about an hour.
Is a better predictor of cardiovascular disease risk than HDL cholesterol testing for CAD risk.
“We developed a cell-free, HDL-specific phospholipid efflux assay for the assessment of CAD risk on the basis of HDL functionality in whole plasma or serum. One of the main advantages of the HDL-SPE assay is that it can be readily automated, unlike the various CEC assays currently in use,” the authors noted in their paper.
Here is how the test is performed, according to the NIH:
Plasma with HDL is separated from the patient’s blood.
“Plasma is added to donor particles coated with a lipid mixture resembling plaque and a fluorescent-tagged phospholipid” that only HDL can remove.
The fluorescent signal by HDL is then measured.
A bright signal suggests optimal HDL lipid removal function, while a dim light means reduced function.
The test builds on the scientists’ previous findings and data. In creating the new assay they drew on data from:
A study of 50 severe CAD and 50 non-CAD people.
A Japanese study of 70 CAD and 154 non-CAD participants.
Examined association of HDL-SPE with cardiovascular disease in a study of 340 patients and 340 controls.
“We have established the HDL-SPE assay for assessment of the functional ability of HDL to efflux phospholipids. Our combined data consistently show that our relatively simple HDL-SPE assay captures a pathophysiologically relevant parameter of HDL function that is at least equivalent to the CEC assay in its association with prevalent and incident CAD,” the researchers concluded in The Journal of Clinical Investigation.
Test May Be Subject to New FDA Rule
While HDL cardiovascular-related research is moving forward, studies aimed at the therapeutic side need to pick up, NIH noted.
“Someday we may have a drug that modulates HDL and turns out to be beneficial, but right now we don’t have that,” said Alan Remaley MD, PhD, NHLBI Senior Investigator and Head of the Lipoprotein Metabolism Laboratory, in the news release.
It may be years before the HDL-SPE test is used in medical settings, the researchers acknowledged, adding that more studies are needed with inclusion of different ethnicities.
Additionally, in light of the recently released US Food and Drug Administration (FDA) final rule on regulation of laboratory developed tests (LDT), the company licensed to bring the test to market may need to submit the HDL-SPE assay to the FDA for premarket review and clearance. That could lengthen the time required for the developers to comply with the FDA before the test is used by doctors and clinical laboratories in patient care.
More research into accelerated aging may lead to new clinical laboratory and anatomic pathology testing biomarkers for early-onset cancer
Could accelerated aging be contributing to the rise in early-onset cancer rates among younger individuals? A recent study conducted at the Washington University School of Medicine in St. Louis (WUSTL) claims the condition may be partially to blame for the increase in cancer diagnoses among young people. But what is accelerated aging, and what tests will clinical laboratories be required to perform to help physicians diagnose early-onset cancer in that age group?
“Accelerated aging—when someone’s biological age [how old one’s cells are] is greater than their chronological age [how long one has existed]—could increase the risk of cancer tumors,” Fox News reported.
In their presentation at the 2024 American Association for Cancer Research (AACR) annual meeting, the WUSTL researchers noted that “individuals born in or after 1965 had a 17% higher likelihood of accelerated aging than those born between 1950 and 1954,” according to an AACR news release.
The scientists studied “the association between accelerated aging and the risk of early-onset cancers,” and found that “each standard deviation increase in accelerated aging was associated with a 42% increased risk of early-onset lung cancer, a 22% increased risk of early-onset gastrointestinal cancer, and a 36% increased risk of early-onset uterine cancer.”
“Multiple cancer types are becoming increasingly common among younger adults in the United States and globally,” said Ruiyi Tian, MPH, a PhD candidate at WUSTL, in the news release. “Understanding the factors driving this increase will be key to improve the prevention or early detection of cancers in younger and future generations.”
Tian was part of the team conducting the study at the Cao Lab at WUSTL. The primary function of this lab is to uncover risk factors for various cancers and develop precision medicine protocols for cancer prevention and treatment.
“Historically, both cancer and aging have been viewed primarily as concerns for older populations,” Ruiyi Tian, MPH (above), a graduate student at Washington University School of Medicine in St. Louis and one of the study’s researchers, told Fox News. “The realization that cancer, and now aging, are becoming significant issues for younger demographics over the past decades was unexpected.” Clinical laboratories and anatomic pathologists will likely be performing cancer testing on younger populations as incidences of early-onset cancer increase. (Photo copyright: Washington University School of Medicine in St. Louis.)
The WUSTL researchers set out to prove that both chronological age and biological age could be determining factors in early-onset cancers. Chronological age refers to the amount of time an individual has been alive, while biological age refers to the age of cells and tissues based on physiological evidence.
“We all know cancer is an aging disease. However, it is really coming to a younger population,” said Yin Cao, MPH, Associate Professor of Surgery at WUSTL and senior author of the study, told CNN. “So, whether we can use the well-developed concept of biological aging to apply that to the younger generation is a really untouched area.”
To perform the research, the scientists examined data of 148,724 individuals between the ages of 37 and 54 located in the UK Biobank database. They calculated each person’s biological age by examining nine biomarkers found in blood:
They then input the data into the PhenoAge algorithm which estimated the biological age of each person.
“Individuals whose biological age was higher than their chronological age were defined as having accelerated aging,” the AACR news release noted.
The next step was to calculate each person’s level of accelerated aging by comparing biological and chronological ages. They then looked at how many of the individuals studied had been diagnosed with early-onset cancers.
For the WUSTL study, early-onset cancers were defined as cancers that were diagnosed before age 55. The researchers found 3,200 cases where such cancers had been discovered.
Faster Agers Twice as Likely to Develop Early-onset Cancer
The scientists then compared the data of people who showed slower aging to those showing faster aging based on the biobank samples. They found that individuals who had the highest accelerated aging were twice as likely to be diagnosed with early-onset lung cancer, had a 60% higher risk of gastrointestinal tumors, and had a more than 80% higher risk of uterine cancer.
“By examining the relationship between accelerating aging and the risk of early-onset cancers, we provide a fresh perspective on the shared etiology of early-onset cancers,” Tian said in the news release. “If validated, our findings suggest that interventions to slow biological aging could be a new avenue for cancer prevention, and screening efforts tailored to younger individuals with signs of accelerated aging could help detect cancers early.”
More clinical studies and research are needed to determine if accelerated aging truly is causing a rise in early-onset cancers. The fact that all of the participants in this study were from the United Kingdom indicates that future studies should include more diverse populations.
Studying accelerated aging’s influence on early-onset cancer may lead to new biomarkers that clinical laboratories and anatomic pathologists can use to help physicians diagnose the condition. Laboratory scientists and pathologists will want to follow any ongoing research and studies on the trend, as ‘accelerated aging’ might be identified as a new disorder to look for when diagnosing and treating cancers.
New ‘simple’ pricing scheme will provide transparency and value to all stakeholders, says company’s Chief Pharmacy Officer
Woonsocket, R.I.-based CVS Health (NYSE:CVS) is planning to scrap what it says is an old-school prescription reimbursement model and turn to a new way to price prescription medications at its 9,000 CVS pharmacies nationwide. Why is this relevant for clinical laboratory and pathology managers? It shows the disruption that is ongoing in healthcare.
Like clinical laboratories, retail pharmacies have significant reimbursement, competition, and labor challenges to address. But unique to retail pharmacies is the emergence of pharmacy benefit management (PBM) companies that work between health insurance plans and drug makers.
“National pharmacy chains found themselves disintermediated from providing prescriptions to patients by pharmacy benefit management (PBM) companies. By 2021, PBMs had captured $484 billion of the total prescription drug spending of $576.9 billion. That meant PBMs controlled 84% of the prescription drug market! That caused retail pharmacies to look for new sources of revenue,” noted Dark Daily’s sister publication The Dark Report.
This arrangement may be motivating retail pharmacy companies to seek ways to recover the volume lost to PBMs.
CVS’ new CostVantage model will work with a formula based on how much CVS paid for the drug, a set markup over those costs, and a fee for pharmacy services to fill the prescription, according to a news release. Some experts and publications have compared the change to the approach used by the Mark Cuban Cost Plus Drug Company.
CVS Health expects to start CostVantage in 2024 before introducing it to PBMs for commercial payers in 2025.
CVS is “committed to lowering drug pricing,” CVS Health Chief Executive Officer Karen Lynch (above), CVS Health’s President and Chief Executive Officer, told CNBC. “What this (the new model) does is it essentially aligns the economics of our pricing for drugs to what consumers will pay at the pharmacy counter,” she added. Clinical laboratory managers and pathologists should understand that this new pricing strategy may be an attempt by CVS to win back prescription business lost to pharmacy benefit management companies. (Photo copyright: Rick Burn/Wikipedia.)
CVS Aims for Value and Transparency
CVS Health’s leaders believe it is time for a change in how the company’s pharmacies are reimbursed by PBMs and other payers.
Generic drugs dispensed in CVS pharmacies reached 90%. “That limits the capacity or the amount of value remaining through the higher levels of generic dispensing,” he said.
Also branded drugs have risen in price about 40% since 2019, leading to “higher costs for patients, our customers’ plans, and PBM plan sponsors.”
“This model has reached an inflection point that is just ripe for change,” Shah said. “We’re changing this outdated reimbursement model that made sense for the last decade, but no longer works today or in the future. We’re introducing a new simple model that provides value for all stakeholders across the supply chain in a much more simple, transparent, and comprehensive way,” he continued.
Cost-Plus Plans versus Retail Drug Prices
Fierce Healthcare compared CVS CostVantage to the Mark Cuban Cost Plus Drug Company, which claims it offers prescription drugs at prices below traditional pharmacies and openly shares with customers the “15% markup over its cost, plus pharmacy fees.”
Some examples on the company’s website include: Abiraterone acetate (generic for Zytiga), a prostate cancer treatment. It is priced at $33.50, compared to $1,093 retail. Cost Plus Drug Company says its costs are:
Manufacturing: $24.60
15% markup: $3.90
Pharmacy labor fee: $5.00
Another drug offered is canagliflozin (generic for Invokana), a type 2 diabetes medication, which sells for $245.92, compared to $676.14 retail. Cost Plus Drug Company says its costs are:
Fein predicts there will be more cost-plus models by retail pharmacies. “Other large pharmacies will likely follow CVS with attempts to force payers and PBMs to accept some form of cost-plus reimbursement,” he wrote.
Fein noted pharmacies prefer cost-plus models for reasons including the “stripping away of complexity and hidden cross-subsidies. … For a pharmacy, the same PBM would pay the same price for the same prescription regardless of the PBM’s arrangement with different plan sponsors.”
Turbulent Retail Pharmacy Market
CVS has also been dealing with limited growth, pharmacist labor relations issues, and a decline in COVID-19 testing, Healthcare Dive reported.
Meanwhile, pharmacies have been closing store sites and affiliated physician practices. CVS announced plans to close 900 stores between 2022 and 2024, according to a news release.
Rite Aid Corporation, Philadelphia, announced last year that it had filed for bankruptcy and may eventually close 400 to 500 of its 2,100 stores.
Walgreens Boots Alliance, Deerfield, Ill., intends to close 150 US and 300 United Kingdom locations, according to its former Chief Financial Officer James Kehoe’s remarks in a third quarter 2023 earnings call transcribed by Motley Fool.
The turbulence in the retail pharmacy market is another sign of ongoing disruption in healthcare. Long-established sectors are experiencing market shifts that are eroding their access to patients and ability to generate adequate profits.
Understanding how pharmacies approach these issues may help medical laboratory and pathology managers develop strategies for adding value to their relationships with healthcare providers and insurance plans.
Lack of regular clinical laboratory screenings in this age group at least partially to blame, researchers say
While cervical cancer rates have seen a 50-year decline overall, that trend is shifting among 30- to 40 year-olds who have experienced a near 2% increase from 2012-2019. This finding comes from a 2024 American Cancer Society (ACS) report that is eyeing the timeline of the human papillomavirus (HPV) vaccines and the lack of clinical laboratory cancer screenings as possible contributors to this new trend.
Though a 2% increase is significant, the study, which was published in CA: ACancer Journal for Clinicians, titled “Cancer Statistics, 2024,” noted that these cancers were “mostly early, curable tumors,” epidemiologist Ahmedin Jemal DVM, PhD, Senior Vice President Surveillance and Health Equity Science at ACS, and senior author of the new report, told NBC News.
To understand how the increase in cancer rates impacts this age group, consider the numbers: “About 13,800 American women are diagnosed with cervical cancer each year and 4,360 die from the disease,” NBC reported.
US vaccination programs for youths have lagged behind nations that have embraced HPV vaccination to positive results.
Australia, for example, has vaccinated a high proportion of its youth since the vaccine was first released in 2006. In 2023, the nation created its National Strategy for the Elimination of Cervical Cancer in Australia program and expects cervical cancer to be fully eliminated there by 2035.
For lab professionals, this demonstrates how new technologies like the HPV test and vaccine can alter how individuals are screened for diseases, and how vaccines can reduce and even eliminate diseases that were once common.
“We need to make sure we are not forgetting about that generation that was a little too old for HPV vaccination,” Jennifer Spencer, PhD (above), Assistant Professor, Department of Population Health and Department Internal Medicine, Dell Medical School, University of Texas at Austin, told NBC News. “The onus is on the healthcare system to think about who is slipping through the cracks,” she added. Lack of clinical laboratory screenings among the 30-40 age group may be contributing to the increase in cervical cancer rates. (Photo copyright: Dell Medical School.)
Lack of Clinical Laboratory Screenings
Research points to a lag in cervical cancer screenings as a possible cause for the recent rise in cases. Timely screening allows doctors to both identify and remove any worrisome lesions before they become cancerous, Jennifer Spencer, PhD, Assistant Professor of the Department of Population Health, Dell Medical School, University of Texas at Austin, told NBC News.
Screenings for women ages 21-65 have fallen 15% since 2000, according to data from the National Cancer Institute. Also, more than half of women with cervical cancer have “either never been screened or haven’t been screened in the past five years, according to the Centers for Disease Control and Prevention,” NBC reported.
The US Preventative Services Task Force recommends that women 21-29 years of age should receive Pap smears every three years. Women 30-65 years of age should do the same, or every five years with an HPV test or combo test.
Despite a decrease in cervical cancer, 29% of women in their 20s are overdue to get screening, NBC noted. This was the age group most likely to be lagging on getting screened. Spencer says that this delay in screening could explain the resulting increase in cervical cancer among the 30-40 age group.
Causes for Lack in Screenings
Regardless of age group, women who were uninsured, in a rural area, non-white, or identifying as lesbian, bisexual, or gay were also more likely to be overdue on screenings, according to Spencer’s study.
In addition, women who just moved to the United States may have missed their screenings, thus increasing risk, epidemiologist Nicholas Wentzensen, MD, PhD, Deputy Director, Senior Investigator, and Head of the Clinical Epidemiology Unit at the National Cancer Institute, told NBCNews.
Additionally, Spencer found in her research that confusion exists by both patients and doctors on when cervical screening should take place. Some participants in her study did not have screening recommended by their doctors, while others simply did not recognize it was necessary.
“When women in one of Spencer’s studies were asked why they hadn’t been screened recently, they commonly said that they didn’t know they needed to be screened or that a health provider hadn’t recommended it. Only 1% [of] women ages 21 to 29 said they had skipped screening because they had received the HPV shot,” NBC News reported.
A 2022 Journal of American Medicine (JAMA) report also looked at screenings as a possible cause. Those researchers found that “only 73% of women with abnormal screening results received follow-up care,” NBC reported.
“If the increase (in cases) is real, it could be a result of missed screening opportunities at earlier ages, as suggested by the increase in squamous cell carcinoma and localized disease. It may also stem from a decrease in screening at younger ages,” the JAMA study authors wrote.
HPV Vaccine and Cervical Cancer Prevention
The HPV vaccine is another important area of research to be considered. Approved in 2006, HPV vaccines were beneficial because HPV “causes six types of cancer, including cervical cancer,” NBC reported.
Women in their early 20s at that time were the first generation to benefit from HPV vaccines, NBC noted. It may be that they continue to benefit in a decrease in cervical cancer among their cohort.
Countries that have emphasized HPV vaccines and stringent screenings in their cancer prevention efforts are reaping the benefits of that policy.
Though cancer screening and the HPV vaccine are important first steps women should take to prevent cervical cancer, follow-through clinical laboratory testing and diagnosis is crucial, Spencer added. This would include additional testing and treatment for any abnormal results of the cancer screening.
However, according to Spencer, “only 73% of women with abnormal screening results received follow-up care,” NBC reported.
Healthcare policymakers today are emphasizing the need for providers to identify and close gaps in care as a way to improve patient outcomes and help control the cost of care. Women who are overdue for a cervical cancer screening test—whether an HPV test or Pap smear—have this care gap. This creates an opportunity for clinical labs to add value.
Clinical laboratories could be helpful during this period by looking at patient files to note which patients are overdue for screenings and then alerting their doctors. Medical labs also could work directly with doctors to establish a program to reach out to patients. Labs would thus be adding value as well as benefitting patients.
