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.
Some experts question the usefulness of Pap testing going forward. But how would cutting back on Pap testing affect clinical laboratory revenue and is it safe for cancer patients?
Recently, a major medical society issued its findings that cervical cancer in the United States has been on a sustained decline for more than a decade and a half. This confirms what cytopathologists and cytotechnologists have watched as the development of new clinical laboratory tests, and the introduction of a vaccine for HPV (human papillomavirus) about 15 years ago, contributed to a reduction in the number of cervical cancer deaths annually here in the United States and in several other nations.
As incidences of cervical cancer declined, so have orders for Pap tests. Thus, clinical laboratory revenues in this area also have declined. This is a change from the 1990s and early 2000s, when Pap tests were the primary screening tool for cervical cancer. About 55 million Pap tests were performed annually during those years and many labs maintained sizeable numbers of cytotechs to perform these tests.
HPV Testing Drove Decreases in Cervical Cancer, Decline in Pap Testing
For at least the past decade, there are pathologists, cytotechnologists, and medical laboratory scientists who graduated from their training programs and began working in labs unaware that, since the 1990s, conventional Pap testing as a major source of test referrals and revenue for clinical laboratories and pathology groups has been on the decline.
What is the reason for the decline? Advances in several areas of medicine, implemented over the past 25 years, have greatly altered how we screen for cervical cancer today. And, in a stepwise fashion, the HPV test and HPV vaccine steadily reduced the role of Pap tests as a primary screening tool.
HPV, a common sexually-transmitted virus, is linked to not only cervical cancer, but also cancers of the vulva, vagina, penis, and anus, according to the Centers for Disease Control and Prevention (CDC) data, which recorded 43 million HPV infections in the US in 2018.
“It is likely that the significant decrease in cervical cancer incidence (in the US) results from clear guidelines for cervical cancer screening and may also reflect promotion and acceptance of [HPV] vaccination, particularly in younger women,” said the ASCO study’s lead author Cheng-I Liao, MD (above), in a news release. Liao is affiliated with Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. (Photo copyright: Healio.)
Cervical Cancer Down, But Other HPV Cancers Up
Though cervical cancer incidence is down, other HPV-related cancers may need additional screening standards to head off rising cancer cases, the ASCO study suggests.
To conduct their study, the ASCO researchers analyzed data for 657,317 people in the US Cancer Statistics (USCS) program from 2001 to 2017. The researchers reported their findings at the 2021 ASCO Annual Meeting held online in June. They include:
Cervical cancer incidence rate decreased each year by 1.03% annually over 16 years.
In the 20 to 24 age group, a “disproportionately higher decrease” of 4.6% per year in cervical cancer incidence rate suggested “potential effect of vaccinations.”
Without screenings, HPV-related cancers incidence increased in women over 16 years.
Oropharyngeal, anal, rectal, and vulvar cancer increased 1.3% in women per year.
In men, oropharyngeal cancer incidence represented 81% of all HPV-related cancers—five times more than cases for women over 16 years.
HPV-related cancers in men increased 2.36% per year over 16 years, and oropharyngeal cancer had the biggest increase.
“Without standardized screening, HPV-related cancers—such as oropharyngeal cancers and anal rectal cancers—are increasing. To reduce these trends and achieve success comparable to what we’re seeing with cervical cancer we must develop effective screening strategies and determine vaccine efficacy in these patient populations,” Liao said in the news release.
Should PAP Tests Be Dropped as a Primary Screen for Cervical Cancer?
Today’s American Cancer Society (ACS) guidelines for cervical cancer screening denote the primary (FDA-designated) HPV test as the “preferred test” for people 25 to 65 years of age. A Pap test (or Pap smear) can be done at the same time, or in instances when a primary HPV test is not available, the ACS said.
HPV screening aims to detect high risk strains of HPV by looking for DNA in cervical cells and the Pap test involves collecting cells from the cervix for review in the medical laboratory for cancer and pre-cancer, the ACS added.
However, pathologists and cytotechnologists who have examined Pap smear slides for many years know that indications of cervical cancer are not always detected by HPV screening. A Pap test often picks up indications of cervical cancer that might not have been detected by the HPV test.
One reason is HPV tests only monitor about 20 of the genetic mutations known to cause cervical cancer. There are about 80 mutations that can cause cervical cancer, but most are so rare, it does not pay to include them in the HPV test panel.
“The Pap is not something that we should look at as replaceable. In some circumstances, we can get a Pap smear that has some significant cellular changes on it,” Jessica Shepherd, MD, an obstetrician and gynecologist at Baylor University Medical Center in Dallas, told USA Today.
Medicine Advancing, Pap Referrals Not So Much
In the 1990s, Pap tests were the front line for cervical cancer screening and a source of about 55 million referrals to clinical laboratories each year, recalls Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“Interestingly, in the past decade, many cytotechnologists and laboratory scientists who started work in labs at the time of the new HPV screening guidelines and vaccination were unaware of the Pap test’s impact on revenue for clinical labs and pathology groups,” he said.
Medical advancements over the past 25 years have altered how providers screen women for cervical cancer and help them prevent it. And as HPV screening and HPV vaccination gained prominence, the standard Pap test became a kind of “co-pilot” to HPV testing. Unfortunately, this meant less oncology referrals to medical labs.
Blame it on the recession of 2008-2010, but the findings are not auspicious for medical laboratories
Salaries and compensation paid to medical technologists (MT) and other skilled clinical laboratory professionals are not keeping pace with yearly increases in the cost of living. This is distressing news for every pathologist and clinical laboratory manager concerned about the constantly growing shortage of MTs and Clinical Laboratory Scientists to staff the nation’s medical laboratories.
For example, one recent national salary survey determined that 24% of laboratorians received no salary increase in 2010! About 42% received an annual increase of between 2% and 4%. Another 20% received just 2% or less. This survey also reported that 28% of medical laboratory professionals received bonuses. These bonuses were based on their salaries or days off in lieu of extra pay. Overall, however, since 2008, this salary survey concluded that salaries for clinical laboratory professionals have increased since 2008.
