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.
By emphasizing HPV vaccinations while having clinical laboratories continue to perform Pap smears, Australia’s rate of cervical cancer has dropped notably
There is currently a global push to completely eradicate cervical cancer and Australia is leading the way with increased funding. It is also focusing on hard-to-reach and underserved populations. Australia is hoping to be first in the world to accomplish this feat by 2035.
For a number of decades, the Pap smear has been the primary screening tool for cervical cancer, as most pathologists and clinical laboratory managers know. However, today it plays a lesser role due to the effectiveness of HPV (human papillomavirus) diagnostic testing, which was put into cervical cancer screening guidelines in 2004.
Then came the first HPV vaccine in 2006. Australia was one of the first nations to implement HPV vaccination programs. By 2010, Australia was working to vaccinate every child. Now, 14 years later, the pool of adults vaccinated against HPV in that nation is causing the rates of cervical cancer to fall.
That means much less cervical cancer test volume for cytotechnologists and cytopathologists, freeing them up to devote their skills to other diagnostic tests.
As the country continues to funnel resources into hitting a zero cancer status, the additional drive will “connect Australia’s world-leading cervical cancer expertise with governments across the region to get HPV vaccine programs up and running, expand screening and treatment, and build health workforce capacity,” said Australia’s Minister for Foreign Affairs office in a press release.
“Australia has always punched above its weight when it comes to cervical cancer, and now Australia is on track to be the first country in the world to eliminate this deadly disease,” said Hon Ged Kearney, MP, RN (above), Assistant Minister for Health and Aged Care and a member of the government’s House of Representatives, in a press release. “By supporting the Pacific and Southeast Asia region [to] eliminate cervical cancer, we are another step closer to ridding the world of this disease.” Clinical laboratories and cytopathologists may soon see less reliance on Pap smears for screening and a shift toward HPV vaccinations to lower the rate of cervical cancer in the US as well. (Photo copyright: Australian Labor Party.)
90% of eligible people will be vaccinated against HPV (including girls and boys).
70% of eligible people will be screened every five years.
95% of eligible people will receive the best possible treatment for precancer and cancer.
In addition to $48.2 million in funding over four years, the program provides:
On the spot testing of samples in First Nations [aka, First Peoples] communities, allowing immediate follow up.
Support for nurses, First Nations health practitioners, and midwives to request pathology for cervical screening.
Increasing support for GPs to undertake colposcopies.
Helping the Underserved
Reaching a wider audience is a large part of Australia’s focus.
“One of my priorities is to address inequities in our health system. I want to make sure that everyone can get access to screening—and all healthcare—no matter where [they] live,” Kearney added. Among the populations sought are First Nations, LGBTIQA+, disabled individuals, and those living away from large cities.
“$8.3 million has been allocated to implement innovate screening models to support such communities,” the Minister for Foreign Affairs office noted in the press release.
Meeting people where they are, and reaching underserved populations, can make a huge difference, especially considering how cervical cancer affects these people. “First Nations women are almost twice as likely to be diagnosed with cervical cancer and face significant barriers to participating in cervical screening compared to non-indigenous women,” the press release notes.
“These tests allow privacy and help to break down barriers for thousands of people who have never screened—including women who have experienced sexual violence, LGBTIQA+ people, and culturally and linguistically diverse and First Nations communities,” the Minister for Foreign Affairs office stated.
There is hope that the push will cause a great shift to other underserved communities as well.
“A quarter of global cervical cancer cases occur in our region, the Indo-Pacific. Tragically, in the Pacific, women are dying at up to 13 times the rate of women in Australia,” said Penny Wong, Australian Minister for Foreign Affairs, in the press release.
How the US Fares in Cervical Cancer Vaccinations
Australia’s vaccination rates far exceed those in the United States. The US government currently recommends HPV vaccination between the ages of 11-12 years old, though it could be administered starting at age nine.
“HPV vaccination is recommended for all persons through age 26 years who were not adequately vaccinated earlier,” the NIH’s National Cancer Institute (NCI) reports.
For years the standard focus for cervical cancer screening has been on the Pap smear. Data show the US lags behind many countries on the rate of HPV vaccination. NCI data show that, as of 2021, in the US just 58.5% of 13-15 year-olds “had received two or three doses of HPV vaccine as recommended,” NCI reported.
With the US’s standard of care still focused on the Pap smear, patients are beginning their cervical cancer prevention journey at a later age. This is because the preliminary age to get a Pap smear in the US is 21 years old, with follow-up exams every three years, the NCI reported.
Even those in this country who are sexually active are not recommended to get screening earlier than 21.
The NCI recommends HPV testing every five years starting at age 30 until 65, with Pap tests every three years.
Clinical laboratories may soon find that, while the US has been slower to get on board with HPV vaccinations, trends in other nations indicate that this may soon change. The reliance that was once placed on the Pap smears prior to 2000 will likely give way to HPV vaccinations at ages and vaccination rates that mirror programs in countries like Australia—where marked reductions in the rate of cervical cancer demonstrate the effectiveness of a successful HPV vaccination program.
Two US clinical laboratories providing testing for the problem-laden program have been targets of lawsuits from women who allege their smear test results were misread
In Ireland, the nation’s health service continues to deal with the consequences from problems with its “CervicalCheck” service that is designed to provide timely screening for the early detection of cervical cancer. It became a national scandal when the news media learned that a number of women had received diagnoses of terminal cervical cancer due to failings in the screening program.
Throughout 2021, news reports have called attention to the efforts of the publicly-funded Health Service Executive (HSE) to regain the trust of women in that country. Earlier this year, TheJournal.ie wrote “the CervicalCheck controversy has been a complex and emotional series of tragedies and mistakes that damaged what is an important, free public health measure for women that could, along with the HPV vaccine, eradicate cervical cancer.”
This ongoing controversy provides cytopathologists and medical laboratory leaders in the US with yet another example of how easily trust in clinical laboratories can be lost when patients lose confidence in the accuracy of test results.
Missed Cancer Results in Nearly $3 Million Settlement
First launched in 2008, Ireland’s CervicalCheck program aimed to screen all Irish women between the ages 25 to 60 for cervical cancer. However, due to a claimed lack of in-house gynecological cytology testing capacity, Ireland’s HSE outsourced the nation’s entire caseload to two lab companies: New Jersey-based Quest Diagnostics and Sonic Healthcare’s Texas-based Clinical Pathology Laboratories (CPL), which received the majority of Irish Pap smear screenings for review.
A decade later, the public became aware of serious misdiagnoses involving the CervicalCheck program. In “Pap Test Errors in Ireland Attributed to Quest, CPL,” Dark Daily’s sister publication, The Dark Report (TDR), noted that 209 women in Ireland had been misdiagnosed in the nation’s cervical cancer screening program.
Concerns about the CervicalCheck program came to light in April 2018 when Vicky Phelan settled a €2.5 (US$2.9) million lawsuit with Ireland’s HSE and with US-based CPL. Phelan had been told that her 2011 Pap smear test result indicated no abnormalities. But a second test three years later revealed she had cervical cancer.
And though CervicalCheck discovered the 2011 false negative result during an internal review, neither the service nor her physician informed Phelan about the error until 2017.
During the Irish High Court proceedings, RTE, Ireland’s national public service media, reported that Phelan’s lawyers argued their client would have had a 90% chance of survival if she had received treatment in 2011.
HSE and CPL settled the lawsuit without admission of liability.
Additional Screenings Identify Hundreds of ‘Suboptimal Colposcopy’ Test Results
Following the Phelan settlement, Ireland’s CervicalCheck released a statement announcing its review of screening tests for 1,482 women diagnosed with cervical cancer between 2008 and 2018. That review identified 208 women whose “screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.”
Of those 208 women, 162 had not been alerted about earlier audits revealing errors affecting their results.
Since then, 308 of the 1,034 women who participated in the program have been identified by a 2019 government-mandated review conducted by the Royal College of Obstetricians and Gynaecologists (RCOG) as having “a different cytology result from the original CervicalCheck result,” an Irish government press release noted.
The RCOG made recommendations for improvements but concluded “the small minority of cases in which suboptimal colposcopy contributed to a missed opportunity to prevent or diagnose a cancer at an earlier stage is probably inevitable when cases that end in cancer are reviewed, but this should not be taken to conclude that colposcopic practice in the CervicalCheck program is substandard.”
Women’s Trust in Ireland’s Cancer-Screening Program Is Broken
The Irish government established the CervicalCheck Tribunal in 2019 to provide the women with an alternate system for adjudicating claims.
“Though a 2019 review of Ireland’s cervical screening program found that it was in line with international standards, questions remain about how the service communicates with women who use it, the State’s method of procuring laboratories, and how to regain trust after waves of scandals,” TheJournal.ie wrote.
According to TheJournal.ie, the “issue at the heart of the CervicalCheck controversy” is HSE’s advice to doctors to not routinely provide smear test audit results to affected patients, but instead to “use their judgement in selected cases where it is clear that discussion of the outcomes of the review could do more harm than good.”
In “Cervical Cancer Controversy: ‘Why Are They Fighting These Women So Badly?’,” The Irish Times pointed out that justice has been elusive for the women whose lives have been lost or damaged by the CervicalCheck debacle. Women who die before their cases are concluded, the paper reported, lose any entitlement to general damages (approximately $587,000), though their families can seek damages for loss of a parent or spouse.
“Why are they fighting these women so badly and making them spend the last few months of their lives fighting for justice for themselves and their children?” asked Lorraine Walsh (on left, with Vicky Phelan on right), a CervicalCheck survivor whose successful, but invasive, treatments for cervical cancer have left her unable to have children. “We have seen how [the late] Ruth [Morrissey] and Vicky [Phelan] and [the late Emma Mhic Mhathúna], and lots of others, have really been put through the mill in the High Court, and we are all wondering if we have to go through that torture just to get justice out of this,” Walsh told The Irish Times. (Photo copyright: The Irish Times.)
Are Women in the US in Danger?
Cian O’Carroll, a solicitor specializing in medical negligence and personal injury law who represents more than 60 CervicalCheck plaintiffs, maintains that women in the US should be concerned about the quality of their laboratory test results as well.
“In quite a number of cases we’re looking at, there are multiple errors,” he told CBS News, adding, “Not only did they get the tests wrong, but they got them very, very wrong.”
The CervicalCheck controversy highlights how quickly a health system and clinical laboratories can lose the trust of the patients they serve. Both Quest Diagnostics and Sonic’s Clinical Pathology Laboratories found themselves in an unwelcome news spotlight in Ireland, given their participation in a cervical cancer screening system that failed in multiple ways the women it was designed to serve.
These events are a reminder to other medical laboratories and pathology groups that accuracy of results is paramount to keeping the trust of patients and healthcare consumers. When a patient’s trust is lost, it is difficult if not nearly impossible to regain.
Professor Peter Sasieni says women vaccinated for HPV may only need two cervical cancer screening tests during their lifetime
Here’s a spicy new subject for debate among pathologists and women’s health specialists. Would it be safe for a woman who has been vaccinated for HPV (human papillomavirus) to get just two cervical cancer screening tests in her lifetime—one at age 30 and the other at age 45? A prominent professor in the United Kingdom recently advocated just such a medical laboratory testing protocol.
Earlier this month, at the United Kingdom’s National Cancer Research Institute conference in Liverpool, England, Professor Peter Sasieni made a presentation about HPV vaccinations and cervical cancer screening that generated press headlines throughout the United Kingdom. Sasieni believes enough progress has been made in vaccinating young women for HPV in the U.K. that it would be clinically appropriate to change the current guidelines for cervical cancer screening. (more…)
