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.
Though a 2019 review of Ireland’s cervical screening programme 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.
When the story first broke in Spring 2018, there was confusion around what exactly had happened. Some people believed that cancer had been missed in the examination of women’s smear tests. But it was cell abnormalities, some of them pre-cancerous, that were misread or acted on incorrectly.
It is accepted internationally there are limits to cancer screening that mean not all abnormalities are spotted. The accuracy rate is at around 75% for cytology smear tests, which looks for all cell changes, and over 90% for the new HPV-first test that Ireland introduced last March.
But the CervicalCheck controversy is about abnormalities that could have been spotted, and in one High Court test case deemed medically negligent that a different action wasn’t taken.
To a certain extent, these are the limitations of cancer screening. But at the centre of this are the women whose lives have been reframed by these limits and human error.
Public health expert Dr Gabriel Scally, tasked with a review of Ireland’s CervicalCheck programme, called some of the initial reporting around the CervicalCheck controversy “terrible” and “deeply misleading”, and criticised that it had become a political issue.
The controversy has never been far from the headlines since it first emerged almost three years ago. This week alone, it was revealed that the future of the CervicalCheck programme may not continue due to the level of mistrust in it, while a political row has begun over Dr Gabriel Scally leaving the role in overseeing CervicalCheck improvements.
So, in an attempt to offer some clarity, here is the story of the CervicalCheck controversy.
The spark: Vicky Phelan
On 25 April 2018, Vicky Phelan settled her High Court case against a US laboratory that had examined her smear test results for €2.5 million.
In 2011, her smear test result had been reported to be clear of abnormalities; three years later she was diagnosed with cervical cancer.
The screening service offers free smear tests at three- to five- year intervals because cervical cancer can take a number of years to develop: between 10-15 years. This way, abnormalities can be spotted quickly and either monitored or treated.
When Vicky Phelan was diagnosed with cervical cancer in 2014, an audit was carried out by CervicalCheck of her smears, as is the protocol when a woman who has previously had a smear test receives a cervical cancer diagnosis, in an attempt to improve the system.
Despite this, and against best practice, Phelan was not told of the audit or the result of it until 2017 – a year after her doctor was first informed about it. The audit found that the result was a ‘false negative’ – which meant that abnormalities were present in her earlier smear, despite it being reported to her as negative.
‘False negatives’ fall into two categories: cervical cell abnormalities that most screeners would not have detected, and ones that most screeners would have detected. Which category a false negative result would fall into depends on each individual smear.
To understand this, it may help to think of analysing smear tests for cell abnormalities as trying to decide on whether hundreds of shades of teal and turquoise are either blue or green. Some of the time, it’s not a black-or-white answer in analysing smears.
In Phelan’s case, her lawyers argued that if this abnormality had been detected in 2011, she would have had a 90% chance of survival. In January 2018, she had been given 12 months to live.
“There are no winners here today,” the Limerick mother of two said outside the High Court.
By refusing to sign a non-disclosure agreement requested by the laboratory, Vicky Phelan sparked a political, scientific questioning of the CervicalCheck programme, and drew people’s attention to over 200 women with cervical cancer who had information about their own health history withheld from them.
The State’s initial response to CervicalCheck
Two days after Vicky Phelan went public, the HSE said that 206 cervical smear results going as far back as 2008 “might” have resulted in a different action – meaning a referral for a cytology examination (173), or a repeat smear at an earlier stage (33).
162 of these women were not told that their smears had been audited; or that the audit had found that a different action should have been taken. Out of the total of 208 women, 17 had died – including Irene Teap, the wife of campaigner Stephen Teap.
The documents show that when sent the audit results of a woman’s smear test, their GPs and doctors were advised to tell them their results, but also 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”. This is the issue at the heart of the CervicalCheck controversy.
Then-Health Minister Simon Harris and then-Director General of the HSE Tony O’Brien agreed to a review of the CervicalCheck programme in response to calls for proof that the cancer screening programme works as it should.
At the time, women who had had a smear test began questioning whether the negative smear test results they had received were actually negative. In response, and against warnings from health experts, Minister Harris ordered free repeat smear tests to anyone who had had a smear test through the CervicalCheck programme.
This would later lead to a backlog in smear tests appointments and results that would eventually prompt officials and health experts in October to urge the minister that it was “essential” to reverse the decision, or else it would cause “unnecessary harm” to women.
A lioness mother: Emma Mhic Mhathúna
On 10 May 2018, 37-year-old Emma Mhic Mhathúna gave her first interview to RTÉ Radio. During the interview, she said that a 2013 smear test came back as clear when it wasn’t, that she was diagnosed with cervical cancer in 2016 – and revealed the heartbreaking news she had received that week that she was dying of cervical cancer.
She had to collect her children from school early and tell them that she was dying. “My gynaecologist said that if my smear test was right in 2013, that I wouldn’t be where I am today. And that’s what makes it so heartbreaking: I’m dying when I don’t need to die.
“My children are going to be without me and I’m going to be without them. I tried to do everything right by breastfeeding and being a full-time mum,” she said, breaking into tears. “And now I’m going to miss out and I don’t even know if my little baby is going to remember me.”
After resisting calls from TDs to resign in the previous days, Tony O’Brien resigned as HSE chief in the wake of this interview.
On 7 October 2018, Emma Mhic Mhathúna died at the age of 37.
On 11 May, then-Taoiseach Leo Varadkar insisted that mediation through the State Claims Agency would be offered in every case, so that no women affected by the CervicalCheck controversy would have to go through the adversarial courts system.
Bravery in the eyes of adversary: Ruth Morrissey
On 26 July, Limerick woman Ruth Morrissey’s case began in the High Court.
Days after the news of Ruth Morrissey’s court case, then-Taoiseach Leo Varadkar admitted that mediation wasn’t “the holy grail or panacea” that he had thought it would be, but said that they would offer it where they could.
The court was told that a 2014 audit found that Ruth’s 2009 and 2012 smears were wrongly reported as normal. The smears were examined by two separate labs: US-based lab Quest Diagnostics and the Sandyford-based firm Medlab Pathology.
Morrissey was not told of the audit until May of that year – 2018 – after Vicky Phelan’s case became public. Morrissey said her doctor told her about the results “because he had to”. Earlier that year, Morrissey was told that her cancer had returned and that it would progress to become terminal.
On 3 May 2019, in what had become a ‘test case’ of the controversy, the High Court awarded Ruth and her husband Paul €2.1 million in damages, after a judge found that a US-based lab that examined her 2009 smear was negligent and in breach of duty, and that a second Dublin-based lab failed to ensure that her 2012 smear sample was adequate for testing.
The judge also said that laboratories should have “absolute confidence” in their decision if they are to give a slide the all-clear. This raised concerns among the medical community that an unrealistic standard was being sought of the screening service.
“Cancer-screening services have limitations that lead to false positive and false-negative results… We are concerned that the standard of absolute confidence mentioned in the judgement by Mr Justice Cross will be impossible to attain,” the RCSI said.
In a Supreme Court appeal of this case taken by the two labs and the HSE, which didn’t contest the financial award to Morrissey, Chief Justice Frank Clarke said that “absolute confidence” may have created “more confusion than clarity”, but relates to the quality of the cervical smear sample:
“…it is clear that all of the relevant witnesses agreed that a screener should not give a clear result in respect of a slide unless they had no doubt but that the sample was adequate and did not contain any suspicious material.”
Although Clarke found that the HSE was not liable for the negligent acts of laboratories, it did have “a duty in respect of patients availing of CervicalCheck”.
Ruth Morrissey would die two months after this verdict, in July 2020 at the age of 39.
When a solicitor for the women affected by CervicalCheck Cian O’Carroll was asked in 2018 whether the court cases compensating these women could undermine the screening programme, he said that cases would only be taken if negligence was evident, and not for every false negative: “…if the error is so significant it amounts to a breach of duty,” as he put it.
He said that the 221 women identified at that point as being affected by the scandal had been selected by CervicalCheck “because of the degree of error”.
These women would form the core group of women and their family affected by the CervicalCheck controversy: the 221+ Patient Support Group.
The Scally Report: Non-disclosure and patient information
After months of delays, Dr Gabriel Scally’s 170-page report into the CervicalCheck programme was published on 12 September 2018.
It was commissioned by the Minister for Health Simon Harris to examine “all aspects of CervicalCheck”, including Vicky Phelan’s case specifically, the non-disclosure of audits, and how information was shared with women about how CervicalCheck worked. A final report was due by the end of June, but was repeatedly delayed.
When completed, it found major shortcomings in terms of disclosure, major deficiencies in the governance of the cervical screening programme, as well as a lack of public health expertise across the screening service.
Although it noted that the programme had been “doomed to fail at some point”, and while listing the effect the non-disclosure of audits had on women as well as the devastating effect of cervical cancer, the Scally Report said that audits had their limits, and that cervical cancer screening programmes in general do “not yet provide the complete answer to preventing, accurately detecting and effectively treating all cases of cervical cancer”.
Among the issues Dr Scally examined as part of his review, were what information was made available to women: both about the limitations of cervical cancer screening, how that compares internationally; and about audits of their smear tests.
For example, Ireland’s CervicalCheck leaflets said that cervical smear screenings “are not 100% accurate”, where as information in Northern Ireland and Wales gave more detailed information of accuracy (“prevents 7 out of 10 cervical cancers”, “75% accurate”).
In a report that looked at how women weren’t informed of their audits, Scally wrote: “it is clear from my discussions with women affected that they attach enormous importance to having unfettered access to their clinical record. Their sentiment can be summed up as, ‘If it’s my body; it’s my record’. I could not agree more strongly.”
In relation to the audits, Scally wrote that there was no system put in place to monitor whether women who had been diagnosed with cervical cancer had been told about their old smears being audited, and whether they wanted to know the outcome of the audit.
Official advice about how to disclose a false positive smear result was that it was left to the judgement of the consultant “as to whether or not disclosure was appropriate”, and CervicalCheck stated that there were “limitations” to the universal implementation of open disclosure.
This, coupled with hesitancy from clinicians – who, Scally wrote, “didn’t regard themselves as part of CervicalCheck”, despite the funding for the colposcopists’ time in providing care to patients referred after screening coming from CervicalCheck – led to a flawed system of open disclosure and apology.
By May 2019, Scally’s review of HSE practices after the CervicalCheck controversy found that the “deeply flawed” policy of open disclosure was still in place.
In his report, Scally also examined the State’s tendering process for tasking laboratories to examine cervical smear slides. Those labs are: Quest Diagnostics in New Jersey; Clinical Pathology Laboratories in Texas; MedLab Pathology in Sandyford; and cytology testing was also carried out at the Coombe Hospital in Dublin.
In relation to the procurement process for hiring laboratories, the Scoping Inquiry said that the State didn’t place enough emphasis on quality assurances: the report said of a 2008 tender that it “underspecifies detail in respect of expected service and quality levels and quality”; in a 2010 request for proposals, the report said “service and quality remain underspecified”.
Similar criticisms were made of a 2012 tendering process, but added that a greater emphasis had been placed on price. The report said: “The Scoping Inquiry found that cost considerations became more prominent over time – in 2008, price was weighted at 20% of the overall tender evaluation, but by 2012 this had risen to 40%.”
But the report concluded that “it is likely that the best proposals were received from the successful bidders”, and without seeing the laboratories’ proposals, “it is not possible to determine whether the successful proposals effectively met the service delivery requirements or whether they were merely superior to unsuccessful proposals”.
Scally recommended against establishing a Commission of Investigation into CervicalCheck on the basis of his findings, and made 53 recommendations, of which 170 actions would need to be taken. Currently, 148 have been fully implemented and 12 others are “in progress”, with Scally writing in April 2020 that he is “satisfied” with the progress made.
Meanwhile, Mr Justice Charles Meenan was tasked at looking at alternative systems for dealing with claims relating to the CervicalCheck programme.
In his report, published in October, he recommended that the Government set up a tribunal to hear claims arising from the CervicalCheck controversy.
Meenan wrote that because “missed” does not mean “negligence”, that liability would still have to be proven that a missed abnormality was medically negligent. Where liability is not contested, the tribunal could be used instead, he said.
When analysing the possibility of a “no-fault” Redress Scheme, used by the State in the case of the Hepatitis C scandal and for symphysiotomy survivors, Meenan said that offering this would not be possible for CervicalCheck because of the liability issue.
The Dáil apology ‘to help heal’
On 22 October 2019, Taoiseach Leo Varadkar formally apologised to the women and the families affected by the CervicalCheck controversy in the Dáil.
Varadkar apologised for very specific issues: a failure of clinical governance, leadership and management; for the humiliation, disrespect and deceit; and for the attempts to play down the seriousness of the debacle.
“A broken service, broken promises, broken lives – a debacle that left a country heartbroken. A system that was doomed to fail.
“We apologise: to our wives, our daughters, our sisters, our mothers – to the men who lost the centre of their lives and who every day have to try and pick up the pieces. The single fathers and grandparents. To the children who will always have a gaping hole in their lives. To all those grieving for what has been taken from them. The happy days that will never be.
“A State apology may not provide closure, but I hope it will help to heal.”
The RCog Review
In December 2019, the UK’s Royal College of Obstetricians and Gynaecologists (RCOG) published the results of its independent clinical review of Ireland’s cervical cancer screening service over a 10-year period.
The investigation, dubbed ‘The RCog Review’, found that the screening service is “in line with internationally respectable programmes”.
Lead author Professor Henry Kitchener – a world expert in gynaecological oncology and cervical screening – said it was “performing effectively and women can have confidence [in it]“.
Out of a total of 1,038 women or their families who agreed to take part, the review disagreed with the CervicalCheck diagnoses in 308 cases (30%). In 159 of these cases (15%), the RCog Expert Panel “considered that the CervicalCheck result had an adverse affect on the woman’s outcome”.
The Review did label more cells as high-grade abnormal, when the original result was classified as either negative or low-grade abnormal. It said in its conclusion:
The pattern of disagreement or discordance was similar in many ways to the pattern seen on routine review of smears prior to the diagnosis of over 8,000 cervical cancers in England.
It should also be noted that when re-examining smear slides as part of the review, screeners were blinded (weren’t told the original smear result), but were aware the slides were part of the RCog review.
As is the case with smear audits, it’s possible that screeners could have erred on the side of caution on whether there was a cell abnormality, as screeners would have been aware that the smear slides were from women who had later developed cervical cancer.
When asked at the launch of the report whether a discrepancy had between found between different laboratories subcontracted by CervicalCheck, the RCog review’s authors said that that fell outside the scope of the report.
The report concluded: “Although some EU countries do have lower cancer incidence and death rates, the full impact of 10 years of CervicalCheck has yet to be realised. Women can have confidence in the CervicalCheck programme. Regular participation is the most effective means of protection against cervical cancer.”
Incidence of cervical cancer had been rising since the late 1970s in Ireland, and was unaffected by the availability of ‘opportunistic’ screening.
Figures indicate that there was a 4% increase per year in the number of people being diagnosed with cervical cancer from 1999-2010.
Between 2010-2015, bearing in mind that the free CervicalCheck programme was introduced in 2008, there was a 6.9% decrease in incidents of cervical cancer per year.
In a statement given after the publication of the report, then-Health Minister Simon Harris gave a statement at Government Buildings to say that “no screening programme in the world will detect all cancers. And that is the difficult, painful reality.”
In a previous interview with TheJournal.ie, Dr Caroline Mason Mohan, Director of Public Health at the National Screening Service, said of the programme: “It’s a quality assured programme, we bring human error down to a minimum, but no programme can get rid of it completely.”
“You can always improve things, you can always make it better. People are in the job they’re in because they believe in screening, and they know it saves lives.”
Where we stand now: The CervicalCheck Tribunal
The complexity of the CervicalCheck controversy is the variation of the cases involved.
In some cases, an argument of medical negligence in how their smears were examined is possible. In other cases, expert opinion concludes that the smear slide was in a scientific grey area, and wouldn’t withstand legal scrutiny.
Some women chose the court case route, others want to avoid it. For the majority of the women, their cancer was caught at an early stage and is treatable, though recurrence is possible.
Dr Nóirín Russell, the current clinical director of CervicalCheck, said this week that if a cancer screening programme leads you to being diagnosed with Stage I cancer, “in Ireland [it's] considered a failure, whereas in every other country it’s considered a success. That’s a very strange place for us to be”.
That is of little comfort to the women who are diagnosed with cancer later than they could have been if smear abnormalities had been labelled a different way.
For the women affected by the non-disclosure of audits, an ex-gratia payment of €20,000 was awarded to them or their families in the wake of both the Scally report (221 women) and the RCog review (159 women) for compensation of the non-disclosure of their smear audits. A package of supports was also provided for these women, such as medical cards and a reimbursement of expenses.
For any alleged medical negligence claims women have about how their smears were read by laboratories, they were left to battle it out with the State and the labs in the courts.
Patricia Carrick, a 51-year-old mother of four, received an out-of-court settlement of €2.75 million and an apology in October 2020. Two months later, she had died. Three of her smear tests – in 2014, 2016 and 2019 – were reported as having no abnormalities. Five months after the 2019 result, she was diagnosed with cervical cancer which had spread to her lymph nodes.
The story of the 32-year-old Longford mother Lyndsey Bennett was another reminder of how questions remain about how Irish cervical smear tests, both private and within the CervicalCheck programme, are examined.
Bennett had four smear tests between 2010 and 2016, and each came back negative.
But 11 months after her 2016 smear test, she went to her GP with symptoms of bleeding, and in January 2017 was diagnosed with cervical cancer, requiring a hysterectomy. In 2018, her cancer returned and she is now seriously ill.
In February this year, Lyndsey Bennett’s court case grabbed the attention of the nation, when it was announced that she had settled her case against the HSE, Quest Diagnostics, and Dublin-based lab Eurofins Biomnis over the reading of her cervical smears.
The case was settled without an admission of liability. “Because I had private smears, I had no choice” but to use the courts system, Bennett told RTÉ’s Late Late Show.
Despite initial pledges from the previous Government that mediation would be provided for women who had been affected by the CervicalCheck programme, many – possibly as high as 150 – are still going through the courts to argue that there was medical negligence in the reading of their smear slides.
There is hope that the CervicalCheck Tribunal could resolve some of those issues. After first being recommended in 2018, the CervicalCheck Tribunal was legislated for in July 2019, and established on 27 October 2020 – though its work was delayed due to the Covid-19 pandemic.
Chaired by Ms Justice Ann Power, it aims to hear and determine claims in respect of CervicalCheck outside of the court process.
But it hasn’t got off to a great start: CervicalCheck campaigners withdrew from the committee to set it up after it became clear that some of their concerns – mostly around recurrence (if cancer returned) – were not going to be met.
Since the Tribunal was set up in October, it has yet to receive a single claim.
Meanwhile, the CervicalCheck programme is striving to encourage as many women as possible to use the free cervical screening service – particularly in the wake of decreasing numbers caused by the Covid-19 restrictions.
CervicalCheck campaigners, health experts, doctors, reports and reviews have all encouraged women to take part in the cervical cancer screening programme, which is free if you’re aged between 25-65 and can be carried out at your local GP.
Since the service has begun, over 100,000 cases of abnormal cervical cells have been found and treated – many of these could have developed into cancer if not found through screening.
The new HPV method of cervical-smear testing, along with a high uptake of the HPV vaccine in schools, is hoped to eradicate cervical cancer entirely – as Australia is on the cusp of doing.
You can check if you’re on the CervicalCheck register here; or read more about the CervicalCheck screening programme, and its new, more accurate form of testing, here.
This article originally stated that women weren’t sure whether they would have to withdraw their High Court case to have their case heard by the CervicalCheck Tribunal.
It has been confirmed that women do not have to drop their High Court case to engage with the Tribunal, but would have to drop their case on the acceptance of a financial sum from the Tribunal. The Tribunal case can also be appealed.
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