Amid public outrage and a growing scandal over cervical cancer screening, in which women were told they were fine and later found to have had cancer after all, the director general of Ireland’s Health Service Executive (HSE) has resigned.
As previously reported by Medscape Medical News, a government-funded screening program in Ireland mistakenly reported negative results to 208 women who were later diagnosed with cervical cancer, from 2010 to 2014. Within this group, 17 women have since died and authorities now believe that many more women may have been affected.
At the heart of the situation is a decision made more than 10 years ago to outsource screening samples to be examined in the United States. At that time, an expert warned against the idea, but Irish officials dismissed the warning.
The HSE runs all of the public health services in Ireland, and director Tony O’Brien had come under increasing pressure to step down as the scandal escalated. Even though he planned on retiring from his position in July, the calls for his resignation intensified as it was revealed that he knew about the situation long before it became public. According to a report in the Irish Mirror, the “final straw for Mr O’Brien’s tenure” was the revelation that he was aware of problems with the screening program as far back as March 2016, even though he repeatedly claimed he had only first heard about it a month ago.
The screening debacle only came to light recently because one Irish victim, Vicky Phelan, 43, who is now terminally ill with advanced cervical cancer, reached a legal settlement of €2.5 million (about $3 million) with the US laboratory company (Clinical Pathology Laboratories) that processed her samples. After reaching the settlement, she then refused to enter into a confidentiality agreement to keep quiet.
But the plot continues to thicken, as the possibility arises that this crisis could have reached beyond Ireland. At least one healthcare system in the United States is investigating the diagnostic accuracy of cervical Papanicolaou (Pap) smears it sends to the same laboratory. There is also heightened concern that the Irish government failed to ensure laboratory quality and that the number of women involved may have been underestimated.
During the last 10 years, the National Cancer Registry in Ireland was notified of 3000 cases of cervical cancer; of those, only 1482 cases were reviewed by the CervicalCheck program. It had been believed that all of the previous tests were re-examined if a woman subsequently received a cancer diagnosis, but now it appears this was not the case. At least 1500 more women have not had their test results reviewed by the national screening service to determine whether the diagnosis could have been made sooner.
Health Minister Simon Harris called the incident a “bombshell” and said that there were possibly a “considerable number of cases” in which women had developed cancer but their screening results had not been audited, according to a report on EOVOKE.ie.
HSE issued an apology in relation to the “evolving situation” around the CervicalCheck scandal.
A “scoping inquiry” began last week, which will dig into multiple issues, including the tendering process and the withholding of audit results from the affected women. In addition, other screening programs will be evaluated as part of the process. The preliminary investigation will be led by Gabriel Scally, MD, a public health specialist from the United Kingdom, and a progress report is expected sometime during the first week of June.
HSE Notified in 2016
Despite growing criticism, O’Brien had previously refused to step down and insisted that he knew nothing about the situation until Vicky Phelan’s lawsuit went public. However, it has now been revealed that O’Brien had been privy to a memo in 2016, warning of the potential false-negative test results. In addition, part of the memo even suggested how to deal with potential headlines in the media, such as “Screening did not diagnose my cancer.”
At a hearing before the Public Accounts Committee, O’Brien insisted the message did not “ring alarm bells” and that the memo issued to him in July 2016 outlined a “communications protocol” in relation to the review of smear tests.
However, the memo says that in February 2016, the CervicalCheck program began informing physicians of the outcome of subsequent audits of Pap smears, which found that women had been incorrectly told that the results were negative. Several of the laboratories that had reviewed the tests had raised concerns about CervicalCheck communicating cytology review findings to treating clinicians.
In addition, a second memo from March 2016 was also sent to O’Brien and outlined legal concerns, as well as discussing the case of a patient who had been diagnosed with cervical cancer and who requested a meeting with CervicalCheck.
In a section called “Next Steps,” the memo stated the following: “that letters to patients should be paused; to await the advice of solicitors; decide on the order and volume of dispatch to mitigate any potential risks; and to continue to prepare reactive communication responses for inflammatory media headlines.”
Finally, the memo also highlighted the need to establish “formal links for statistical reporting with the National Cancer Registry Ireland (NCRI),” but CervicalCheck had known for many years that there were issues with the transfer of data from the NCRI.
Needless to say, the HSE and the CervicalCheck program have been strongly criticized in the Irish media over the lack of follow-up with physicians and for not ensuring that all patients included in the audit process had been notified.
Lowest Bidder
The Irish saga continues to unfold, as there are now “serious fears” that the quality of the labs evaluating the tests may not have been adequately investigated and that officials prioritized getting the service for the cheapest price, says a report in the Irish Examiner.
Tender documents suggest that contracts awarded on behalf of the government, to test cervical smear tests, were awarded in 2012 based on the cheapest price available, notes a report in The Independent. A notification published after the procurement process states that both Quest Diagnostics and MedLab Pathology were awarded their contracts based on the “lowest price” without any other details on criteria, it adds.
MedLab Pathology is affiliated with Clinical Pathology Laboratories, the company named in Phelan’s lawsuit. A 2-year contract to carry out screening services on behalf of the Irish National Cancer Screening Service (NCSS) was awarded to Quest Diagnostics in 2008, and in 2010, the NCSS conducted a second procurement process and extended that contract for an additional 2 years. A contract to Clinical Pathology Laboratories was also awarded through MedLab Pathology, but in 2012, the NCSS was once again advertising for testing services.
The documents stated that bids would be subject to a scoring system wherein 400 of the 1000 marks were based on “ultimate costs,” 550 for “proven ability and methodology to meet NCSS service requirements,” and 50 for “value-added services.” In addition, it also stated that “the contract will be awarded to the most economically advantageous tender submitted on the basis of the following anticipated award criteria” but that the NCSS reserved the right to “develop these more fully or alter them.”
More Lawsuits and More Women Affected
Vicky Phelan is not the only woman who has sought legal action against government agencies and the pathology labs, although except for one other case, the others have not yet been resolved, according to The Independent.
O’Brien has now revealed to the Oireachtas Health Committee that there are 10 active legal cases involving the CervicalCheck program, and of these, 6 have reached the point of legal proceedings, while the other 4 are at the “pre-legal proceedings” stage.
Court records also show that 5 cases had been initiated in recent years wherein MedLab Pathology is named as a defendant or co-defendant, and another 5 cases were initiated against Quest Diagnostics. One was settled in 2014 with no admission of liability, but it involved a 2011 smear test analysis where abnormalities were missed.
Baylor Investigates
Across the Atlantic, Baylor College of Medicine in Houston, Texas, has initiated a review of the accuracy of Pap smears that were collected at Baylor Clinic and outsourced to Clinical Pathology Laboratories, which is based in Austin, Texas.
In response to an inquiry by Medscape Medical News, Baylor stated that they contract with Clinical Pathology Laboratories, in addition to other laboratories, to read Pap smears that are collected at Baylor outpatient clinics. “We have reached out to Clinical Pathology Laboratories, Inc. to ascertain the accuracy of diagnoses for our patients and will do what is necessary to ensure the safety of our patients,” said Baylor. “At this time it is not known how many of our patients could have been impacted by the possible inaccurate reading of pap smears. The College has launched a full review and any patients affected will be contacted.”
Baylor College of Medicine provides medical direction of Clinical Pathology Laboratories’ clinical laboratory operations in the greater Houston area, including “overseeing tests such as the analysis of blood, body fluid and urine specimens, for outpatient services at Baylor Clinic.”
Pap smears taken at the Baylor Clinic are the only ones that are sent to Clinical Pathology Laboratories. Smears from their other facilities, such as the Kirby Clinic Family Practice, and from the Baylor obstetrics and gynecology department, are analyzed by different laboratories.
It is unclear what other facilities or physicians in the Houston area may have sent Pap smears to Clinical Pathology Laboratories. According to a report in the Houston Chronicle, MD Anderson Cancer Center, Houston Methodist, UTHealth Physicians, and Memorial Hermann, as well as Baylor affiliates CHI St. Luke’s and Ben Taub, have stated that they do not use this particular lab.
Clinical Pathology Laboratories has not responded to requests by media.
Expert Perspectives on Cervical Screening
Two experts not involved in the Irish issue have offered Medscape Medical News some general perspectives on cervical cancer screening.
Christine Noga Booth, MD, chair of the Cytopathology Committee at the College of American Pathologists, pointed out that there is no “perfect lab test.”
However, one way to minimize false-negative results is by co-testing, and Booth pointed to a large 2016 study that found false-negative results were similar for high‐risk human papillomavirus (hrHPV) testing (8.7%) and Pap tests (9.1%). However, the false‐negative rate for cytology‐hrHPV co-testing was only 1.2% (Cancer Cytopathol. 2016;124:317-323).
“As a quality assurance measure, performing testing on patients with both high-risk HPV and Pap smears actually decreased the false-negative rate significantly,” she said. “I think that is a way to minimize the false-negative rate.”
Booth said that she doesn’t know if any of the Irish patients had undergone co-testing, “but that is something that we do in the US.”
Another way that false-negatives are minimized in the United States are by federally mandated requirements. The Clinical Laboratory Improvement Act of 1988 (CLIA ’88) mandates strict quality-control measures for laboratories that interpret cervical cytology smears. “It mandates at least 10% prospective rescreening of every negative Pap test by every cytotechnologist before cases are signed out,” explained Booth. “And those have to be re-screened by a qualified supervisory-level cytotechnologist or a pathologist before reporting those results.”
While outsourcing Pap smears to the United States became a prominent issue as the situation in Ireland unfolded, Booth noted that outsourcing in and of itself is not a problem. “It becomes a problem when you don’t have the medical history and health information for the patient,” she said. “It can be more difficult to interpret the slide if the clinical history is not known.”
Stephanie V. Blank, MD, director of gynecologic oncology, Mount Sinai Health System in New York City, noted that “cervical cancer is a preventable disease and the best way to prevent it is to have boys and girls receive the HPV vaccine prior to sexual debut.”
She told Medscape Medical News that “co-testing or HPV testing alone would likely have resulted in fewer false-negatives.”
“Getting Pap smears plus HPV testing at the interval suggested by your provider is the best way to avoid this situation,” said Blank. “The more times your sequential tests are negative, the better the negative predictive value — that is, how accurate a negative test is a true negative.”
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