South Asian nation aims to do what US, UK, and Europe failed to do during start of COVID-19 pandemic and slow spread of disease while case counts are low
With monkeypox quickly spreading around the world, India may be taking a lesson from western nations’ delayed response to COVID-19—including a sometimes slow availability of clinical lab testing for monkeypox—and preemptively increasing its national surveillance of the deadly social disease.
On Aug. 29, the Hindustan Times reported that in an attempt to slow the spread of monkeypox, India’s central government “has designated 15 viral research and diagnostic laboratories (VRDLs) spread across 13 states to monitor the incidence of monkeypox in the country.”
In the United States, the disease has spread with alarming speed, reaching all 50 states, as well as Washington, DC, and Puerto Rico. At 23,893 confirmed cases as of Sept. 14, the US now has the most cases in the world, according to the federal Centers for Disease Control and Prevention (CDC).
Reuters reported on Aug. 4 that the US Department of Health and Human Services (HHS) had declared a public health emergency. It was in May when monkeypox was detected in the United Kingdom (UK). Both the UK and several countries in Europe have struggled to control spread of the disease.
India hopes its decision to designate 15 VRDLs across 13 states to monitor the disease’s spread will enable it to do a better job than other countries at containing or eradicating monkeypox in the nation of 1.4 billion people, the Hindustan Times reported.
“The probability of containment is diminishing daily,” American infectious disease epidemiologist Anne Rimoin, PhD, a monkeypox expert at the UCLA Fielding School of Public Health, told STAT. “It’s really unfortunate because we do have the tools. This is not an unknown virus … We have vaccines that are already available, even vaccines with indications for monkeypox. Therapeutics. And we know what’s needed to be done.’’ Clinical laboratory testing for monkeypox will certainly increase over the coming months. (Photo copyright: KTLA.)
Keeping Up Their Guard
“Fortunately, India has not seen a surge in cases and the situation here is well under control. However, we cannot drop the guard just as yet. Therefore, a network of VRDLs has been established for surveillance purposes,” a top government expert told the Hindustan Times, seeking anonymity. “It will help pick signs early in case more cases get reported.”
As of Sept. 19, 2022, India reported just 12 cases of monkeypox resulting in one death, while, as noted above, the US had 23,892 confirmed cases and one death, according to CDC statistics. In the UK, confirmed cases totaled 3,552 with no deaths. And, as of that date, the European Union reported 19,379 confirmed cases.
Until recently, monkeypox was endemic only in West and Central Africa. India reported its first case of monkeypox on July 14. So far, most, but not all, of its cases have been related to international travel.
“The isolated cases of monkeypox reported in Delhi with no prior travel history emphasize the importance of tracing the source of the infection, perhaps transmission through rodent population,” Diwakar Kulkarni, PhD, former Director and Principal Scientist at the Indian Council of Agricultural Research, National Institute of High Security Animal Diseases, told Think Global Health.
Homosexuality a Vector in India
While India’s scientists are focused on containing the monkeypox outbreak, the country’s government may encounter societal roadblocks because of the disease’s connection with homosexuality. Gay sex is believed to be fueling the spread of the disease, ABC News reported. Until a Supreme Court of India ruling in 2018, gay sex was punishable by up to 10 years in prison in India.
Virologist and noted HIV expert Ishwar Gilada, MD, who opened India’s first AIDS clinic in 1986, told Bloomberg “anti-gay stigma” in India is causing male patients to avoid getting tested and treated for the disease. He said even before the first monkeypox cases were reported in India, two of his patients—a gay man and a man who identified as bisexual—refused to get tested because they feared being the first monkeypox case in the country.
“They are going underground,” Gilada told Bloomberg.
Did the US Wait Too Long to Begin Testing for Monkeypox?
The rapid growth in cases worldwide and the geographic spread of the disease has left global health experts pessimistic monkeypox can be contained.
NPR reported in June that some experts believe public health agencies ran too few tests in the early months of the outbreak because state health officials used a narrow definition of monkeypox when determining who qualified for testing, and that the US had “dropped the ball” on monkeypox testing.
As of Sept. 19, 2022, there were 62,406 confirmed cases worldwide, according to the CDC.
As clinical laboratories attempt to recover from the workload created by the COVID-19 pandemic, monkeypox appears to be the next endemic to test the mettle of lab professionals. Only time will tell if America and other western nations failed to act as expeditiously as India in curbing spread of this latest deadly disease.
The federal agency shipped tests to five commercial clinical laboratory companies, augmenting efforts by public health labs
Medical laboratories in the US are ramping up their efforts to respond to an outbreak of monkeypox that has been spreading around the globe. Microbiologists and clinical laboratory scientists will be interested to learn that this infectious agent—which is new to the US—may be establishing itself in the wild rodent population in this country. If proved to be true, it means Americans would be at risk of infection from contact with rodents as well as other people.
The Centers for Disease Control and Prevention (CDC) announced on May 18 that it had identified the infection in a Massachusetts resident who had recently traveled to Canada. As of August 3, the federal agency was reporting 6,617 confirmed cases in the US.
“Because there are no other non-variola orthopoxviruses circulating in the US, a positive test result is presumed to be monkeypox,” states the APHL press release.
“As we focus on the US response, we keep a close watch on the global outbreak. Infectious diseases don’t respect borders, as we know,” said Chris Mangal (above), director of public health preparedness and response, APHL, in a press release. “I am proud of how LRN member laboratories have rapidly and effectively responded to this emergency. This is precisely what the LRN was intended to do. Should this outbreak continue to grow, preparing for expanded testing and increasing capacity beyond LRN laboratories is important to ensuring we are ready for a surge in testing.” (Photo copyright: Association of Public Health Laboratories.)
Commercial Labs Get Involved
Seeking to bolster testing capacity, the federal Department of Health and Human Services (HHS) announced on June 22 that the CDC had begun shipping OrthopoxvirusPCR tests to five commercial lab companies. They include:
“By dramatically expanding the number of testing locations throughout the country, we are making it possible for anyone who needs to be tested to do so,” said HHS Secretary Xavier Becerra in an HHS press release.
Labcorp was first out of the gate, announcing on July 6 that it was offering the CDC-developed test for its customers, as well as accepting overflow from public labs. “We will initially perform all monkeypox testing in our main North Carolina lab and have the capacity to expand to other locations nationwide should the need arise,” said Labcorp chief medical officer and president Brian Caveney, MD, in a press release.
Mayo Clinic Laboratories followed suit on July 11, announcing that the clinic’s Department of Laboratory Medicine and Pathology would perform the testing at its main facility in Rochester, Minnesota.
“Patients can access testing through Mayo Clinic healthcare professionals and will soon be able to access testing through healthcare professionals who use Mayo Clinic Laboratories as their reference laboratory,” Mayo stated in a press release.
Then, Quest Diagnostics announced on July 13 that it was testing for the virus with an internally developed PCR test, with plans to offer the CDC test in the first half of August.
The lab-developed test “was validated under CLIA federal regulations and is now performed at the company’s advanced laboratory in San Juan Capistrano, Calif.,” Quest stated in a press release.
Public Health Emergency?
Meanwhile, the CDC announced on June 28 that it had established an Emergency Operations Center to respond to the outbreak. A few weeks later, on July 23, World Health Organization (WHO) Secretary-General Tedros Adhanom Ghebreyesus, PhD, declared that the outbreak represented “a public health emergency of international concern.”
He noted that international health regulations required him to consider five elements to make such a declaration.
“WHO’s assessment is that the risk of monkeypox is moderate globally and in all regions, except in the European region where we assess the risk as high,” he said in a WHO news release. “There is also a clear risk of further international spread, although the risk of interference with international traffic remains low for the moment. So, in short, we have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the International Health Regulations.”
Still, public health authorities have made it clear that this is not a repeat of the COVID-19 outbreak.
“Monkeypox virus is a completely different virus than the viruses that cause COVID-19 or measles,” the CDC stated in a June 9 advisory. “It is not known to linger in the air and is not transmitted during short periods of shared airspace. Monkeypox spreads through direct contact with body fluids or sores on the body of someone who has monkeypox, or with direct contact with materials that have touched body fluids or sores, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.”
The New York Times reported that some experts disagreed with the CDC’s assessment that the virus “is not known to linger in the air.” But Professor of Environmental Health Donald Milton, MD, DrPH, of the University of Maryland, told The Times it is still “not nearly as contagious as the coronavirus.”
The Massachusetts resident who tested positive in May was not the first known case of monkeypox in the US, however, previous cases involved travel from countries where the disease is more common. Two cases in 2021—one in Texas and one in Maryland—involved US residents who had recently returned from Nigeria, the CDC reported. And a 2003 outbreak in the Midwest was linked to rodents and other small mammals imported to Texas from Ghana in West Africa.
“Labcorp and Quest don’t dispute that in many cases, their phlebotomists are not taking blood from possible monkeypox patients,” according to CNN. “What remains unclear, after company statements and follow-ups from CNN, is whether the phlebotomists are refusing on their own to take blood or if it is the company policy that prevents them. The two testing giants say they’re reviewing their safety policies and procedures for their employees.”
One symptom of monkeypox, the CDC states, is a rash resembling pimples or blisters. Clinicians are advised that two swabs should be collected from each skin lesion, though “procedures and materials used for collecting specimens may vary depending on the phase of the rash.”
“Effective communication and precautionary measures between specimen collection teams and laboratory staff are essential to maximizing safety when manipulating specimens suspected to contain monkeypox virus,” the CDC notes. “This is especially relevant in hospital settings, where laboratories routinely process specimens from patients with a variety of infectious and/or noninfectious conditions.”
Perhaps the negative reaction to the CDC’s initial response to the COVID-19 outbreak in the US is driving the federal agency’s swift response to this new viral threat. Regardless, clinical laboratories and pathology groups will play a key role in the government’s plan to combat monkeypox in America.
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.
Doctors’ advocacy organization praises potential of ‘My Health Record’ but voices concerns about functionality, interoperability, and added burden placed on providers
Australia’s goal of implementing a nationwide electronic health record (EHR) system received a major boost when the country’s largest pathology laboratories signed agreements with the Australian Digital Health Agency (ADHA) to join the project. But the My Health Record system has yet to fully win over providers as the Australian Medical Association (AMA) raises concerns over functionality, interoperability, and the added burden placed on healthcare providers.
ADHA Chief Executive Tim Kelsey praised the addition of pathology and diagnostic organizations to the My Health Record platform. In Australia, pathology laboratory is the term to describe what are called clinical laboratories in the United States.
“The largest diagnostic organizations in Australia have now agreed to share their test reports with Australian consumers,” Kelsey said in an ADHA news release. “We are working to deliver a My Health Record for all Australians next year, unless they choose not to have one. Health consumers will benefit from this significant commitment by the pathology industry and their software partners.”
Australian Digital Health Agency CEO Tim Kelsey says his agency in 2018 will be creating a universal electronic health record for all the country’s 24.8 million citizens, though patients will have the option to opt out of the My Health Record project. He called the “significant commitment” of pathology labs to the project a major step forward. (Photo copyright: ADHA.)
In May 2017, Sonic Healthcare, Australia’s largest pathology provider, became the first private pathology company to join the My Health Record initiative. That news was followed by agreements between the ADHA and pathology companies Primary Health Care, Australian Clinical Labs, and seven other software vendors and pathology laboratories, including:
The ADHA also finalized service agreements with additional software companies that will enable diagnostic imaging providers to link up to My Health Record by the end of 2018.
AMA Says My Health Record Lacks Functionality and Critical Features
In 2012, Australia announced the roll out of the Personally Controlled Electronic Health Record, the original initiative to create a citizen-controlled secure online summary of health information, which later was renamed My Health Record. According to The Australian, more than 5.3 million Australians are now using My Health Record, a 500% increase in the number of shared health summaries uploaded in 2016-2017 and a 200% rise in interoperability with private hospitals.
Royal College of Pathologists of Australasia President Bruce Latham, MBBS, welcomed the announcement of the increased functionality for My Health Record.
“The Australian pathology sector has been working in support of the national eHealth agenda for a number of years,” Latham stated in the ADHA news release. “Work is now progressing to connect both public and private labs to the My Health Record, and patients nationally will start to see their pathology reports in their My Health Record.”
Developers and program administrators of My Health Record predict it will generate savings of AU$123 million from:
Reduction in adverse drug events;
Fewer duplicated diagnostics tests; and,
Cost savings by 2020-2021.
However, the AMA, Australia’s doctors’ advocacy group, outlined its concerns about My Health Record in a Pre-Budget Submission to the Australian federal government. While praising the project’s potential to “not only save money, but save lives,” the AMA argued the national repository of healthcare information needs improved features and functionality to meet its potential.
“… more work is required,” the AMA wrote. “The return on investment will hinge in the short term on ease of use for medical practitioners who upload the clinical data. Interoperability with the multiple software packages used across the medical profession and broader health sector must be seamless.
“Problems uploading specialists’ letters, poor search functionality, time-consuming adaptations to existing medical practitioner work practices, or inappropriate workarounds will erode clinical utility and deter doctor use—and, more importantly, take time away from focusing on the patient,” the AMA concluded.
Automatic Enrollment Concerns AMA
My Health Record began as a self-register model, but as the program goes nationwide in 2018, it will do so using an “opt-out” model. This means citizens will be enrolled automatically unless they ask to be removed from the program. According to the ADHA, the automatic creation of My Health Record for all Australians will begin in mid-2018. The government’s goal is to provide access to My Health Record to all 24.6 million Australians by June 30, 2018.
The federal government’s switch to an opt-out system for My Health Record drew concerns from the AMA.
“Doctors do not have time to talk their patients through the My Health Record arrangements for opt-out, privacy, [or] setting access controls in standing consent for health providers to upload health information. This is the work of the government. Doctors must be allowed to focus on what they do best—caring for patients,” the AMA stressed.
Clinical Laboratories Have Stake in Outcome
According to Healthcare IT News Australia, the Australian government has spent AU$2 billion ($1.53 billion USD) so far developing what could become a white elephant if general practitioners and hospital groups don’t see a clinical benefit in its use.
If Australia is successful in creating a fully-functioning and widely-used national repository for health information, it will be among the first countries to do so. In 2002, the United Kingdom (UK) kicked off a nearly decade-long effort to create a national EHR system for the UK’s single-payer tax-supported health system. Ultimately, the government pulled the plug on the initiative after spending 12.7 billion pounds ($17 billion USD) trying to complete the project.
That result, and lessons learned from Australia’s experience, should inform American healthcare policy makers. It remains a daunting effort to implement a single electronic patient health records system. Of course, pathologists and clinical laboratory administrators have an interest in this issue, since medical laboratory test data represents the largest proportion of an individual patient’s permanent health record.
Other clinical laboratory organizations responding to the RFP were Laboratory Corporation of America, Quest Diagnostics Incorporated, and Mayo Clinic
Last Friday, Alberta Health Services (AHS) in Edmonton, Alberta, announced that Sonic Healthcare Limited (SHL.AX), of Sydney, Australia, has been selected as the medical laboratory testing provider to serve Edmonton and parts of central and northern Alberta. This agreement is worth $3 billion Canadian over 15 years and is believed to be the world’s biggest clinical laboratory testing contract currently out for bid.
Competition for this clinical laboratory testing contract was intense. Last April, four organizations were identified as having submitted responses to Alberta Health Service’s (AHS) request for proposals (RFP). They were: (more…)
