Following a nearly two-year disruption due to the SARS-CoV-2 pandemic, pathologists and clinical laboratory professionals once again have an opportunity to gather and learn from each other
It is good news that the daily number of new cases of COVID-19 continue declining here in the United States. That fact, and the growing number of vaccinations, have encouraged state and federal officials to lift many restrictions on business and social activities.
Clinical laboratories are watching a big drop in the daily number of COVID-19 tests they perform, even as routine test volumes climb and more patients show up in doctors’ offices for the typical mix of ailments and health conditions.
It’s true that many familiar routines are back. But it is also true that things are not exactly the way they were pre-pandemic. And that’s the rub. Going forward, what should medical laboratory managers and pathologists expect to be the “post-pandemic normal” in how patients access care and how providers deliver clinical services? How will healthcare in this country be different from what it was pre-pandemic?
Preparing Clinical Lab Leaders for What Comes Next
These questions and more will be front and center when the Executive War College on Lab and Pathology Management returns on Nov. 2-3, 2021, at the Hyatt Riverwalk Hotel in San Antonio. The theme of this first live gathering since the spring of 2019 will be “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.”
“Today, lab managers have the interesting challenge of understanding the new opportunities they can use to advance their labs, both clinically and financially,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “It isn’t that the pandemic changed healthcare in fundamental ways. Rather, it is that the pandemic accelerated changes that were underway before the outbreak began.
“That’s true of telehealth as well, for example,” he continued. “Once the nation was locked down, utilization of virtual physician visits and telehealth services skyrocketed. Today, national surveys confirm that as many as 50% of all patients and physicians have used a telehealth service, are comfortable with this type of appointment, and are ready to continue to use virtual office visits.
Robert Michel (above), Editor-in-Chief of Dark Daily, its sister publication The Dark Report, and founder of The Dark Intelligence Group, will host the first live edition of the Executive War College since May 2019 in San Antonio. The theme will be “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.” Attendees from clinical laboratories and pathology groups will gain critical insights they can act on immediately. (Photo copyright: The Dark Report.)
“Another trend accelerated by the pandemic is patient self-testing at home,” Michel added. “Government health officials saw the benefit of clearing for clinical use different specimen collection systems and COVID-19 test methods designed for use by consumers in the comfort of their home. Today, consumers can choose from multiple specimen collection products and SARS-CoV-2 tests designed for in-home use. Clinical laboratory managers should consider this development to be a consumer home-test baseline. Federal officials have created a regulatory pathway that will make it easier and faster for federal regulators to clear other types of diagnostic tests for consumer home use.”
What if the FDA Approves More Consumer At-Home Tests?
There are implications to each of the two trends described above. In the case of telehealth, if patients see their doctors virtually and the doctors order medical tests, how do clinical laboratories access these patients to collect the specimens needed to do this testing?
Similarly, if, in coming years, the federal Food and Drug Administration (FDA) increases the number of diagnostic test specimen-collection kits that consumers can use from home, how should local clinical laboratories position themselves to receive those kits and perform those tests?
These are two examples of important questions to be answered at sessions scheduled for the Executive War College in San Antonio on Nov. 2-3. Case studies by innovative lab leaders will address topics ranging from high-level strategy to daily management, operations, marketing, and managed care contracting.
Attendance Limited at This Fall’s Executive War College
At the first live edition of the Executive War College since May 2019, attendees will notice one significant difference from earlier years. By design, and for the safety and well-being of attendees, the number of attendees will be limited to 300. The hotel follows the Centers for Disease Control and Prevention (CDC) guidelines and is prepared to adjust those numbers as CDC guidance evolves. Thus, those interested in attending this year’s conference are advised to register early to guarantee their place and avoid being disappointed.
Suggestions for session topics and speakers are welcome and can be sent to info@darkreport.com. Conference details, session topics, and speakers will be updated regularly at www.executivewarcollege.com.
So, register today because seating is limited at the 2021 Executive War College Presents “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.” To ensure your place at this valuable conference, click HERE or place this URL (https://dark.regfox.com/2021-ewc-presents) into your browser.
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.
Outspoken Wecht wants readers to understand ‘the multifaceted challenges of the interface of law and medicine’
Pathologists will recognize the name of nationally-acclaimed forensic pathologist Cyril Wecht, MD, JD, who for more than a half-century has been at the center of many of the country’s highest-profile civil and criminal cases. Thus, Dark Daily readers will be intrigued to learn the so-called “godfather of forensic pathology” has published a memoir that takes readers behind the scenes of many of his most controversial forensic pathology cases.
In his recently published memoir (above), forensic pathologist Cyril Wecht, MD, JD, offers readers an inside look at some of his most controversial cases, as well as a defense of his own brushes with the legal system. Anatomic and clinical pathologists may be especially intrigued by Wecht’s description of how “he was acquitted on charges of personally profiting from his office as Allegheny County Coroner” during a federal public corruption charge that was dismissed in 2008, the book’s description states. (Photo copyright: Exposit Books.)
A ‘No-Holds-Barred’ Account
According to TribLIVE, the book—written by Wecht and award-winning writer/filmmaker Jeff Sewald—is a “no-holds-barred account” of Wecht’s personal and professional life. Among the more interesting tidbits are details regarding Wecht’s 1972 discovery that JFK autopsy materials and specimens had gone missing.
“They had been in the government’s possession, so nobody could have touched them, but now the metal container which has held John Kennedy’s brain in formalin was no longer on the list of contents. In addition, various photographs and microscopic tissue slides were also no longer listed. The President’s brain was missing!” wrote Wecht, who argued Lee Harvey Oswald did not act alone in killing JFK and may not have fired the shots that killed him.
In 2006, Wecht faced an 84-count federal public corruption trial, which resulted in him resigning as Alleghany, Pa. medical examiner, the Pittsburgh Post-Gazette reported. In his memoir, Wecht wrote extensively about his public corruption trial. TribLIVE noted Wecht “expresses particular disgust” over the accusation that he supplied Pittsburgh’s Carlow University with cadavers in exchange for use of their laboratory space for his own practice. His trial ended in a hung jury.
“The body-snatching issue was seized upon by the media and was the subject of some of the most horrible cartoons ever,” Wecht wrote. “What made them especially horrible was the fact that I believe anti-Semitism was at their core. They made me look wicked and shadowy, like a ‘Shylock’ who was willing to stoop as low as selling human corpses for a handful of shekels. It was sickening.”
Wecht became known nationally through media appearances and his many decades of work as a medical-legal consultant in civil and criminal cases. At the 2000 Forensic Science and the Law Conference, television host and political commentator Geraldo Rivera, JD, stated, “I’ve known Cyril Wecht for most of my 30-year broadcasting career, and my respect for him has only grown over the decades. His skills as an attorney, as a pathologist, as a medical examiner are legendary.
“Dr. Wecht has guided my audiences through our coverage of crimes ranging from the Kennedy assassination to the O.J. Simpson trial to the JonBenet Ramsey murder mystery,” Rivera added. “And whether or not my audiences knew it, they were getting an education in forensic science—and a lesson in how medical science is applied to this country’s criminal laws.”
An ‘Expert’ and an ‘Irritant’
Though also certified in anatomic pathology and clinical pathology, Wecht has spent his career as a forensic pathologist focused on determining the cause of death. He has performed approximately 17,000 autopsies and has supervised, reviewed, or been consulted on approximately 30,000 additional postmortem examinations, the Cyrilwecht.com website states.
Cyril Wecht, MD, JD (above), told the Pittsburgh Jewish Chronicle that he wrote this memoir so readers could understand the “… complexity and the multifaceted challenges of the interface of law and medicine, specifically in the realm of pathology, and how important it is for justice to be served, with the input from forensic science, and how the system can be subverted, perverted, suppressed, and manipulated.” (Photo copyright: Pittsburg Business Times.)
Pathologists who followed Wecht’s career may know of his reputation “as both an expert and an irritant,” noted the Pittsburg Post-Gazette. For his part, Wecht stated, “If I had been a bit more diplomatic and patient, and a little less antagonistic and controversial, I might have achieved more,” the newspaper reported.
Anyone interested in forensic pathology will likely enjoy reading the behind-the-scenes stories from Wecht’s more than six decades of work. But Wecht’s memoir should be particularly intriguing and informative for clinical and anatomic pathologists, as well as all medical laboratory scientists.
