The Irish Times

Audit controvers­y still hangs over CervicalCh­eck

Restoring public trust in screening service vital to success of cancer treatment in future

- Paul Cullen Health Editor

It should be a good news story: a women’s health service, led by women, using new technology to screen for cervical cancer and saving up to 100 lives a year.

Instead, three years after being mired in controvers­y, CervicalCh­eck remains in the doldrums, struggling to win the trust of women and to recruit qualified staff.

Attendance­s for screening were more than 100,000 down on expectatio­ns in (coronaviru­s-affected) 2020 and plans to open a new screening laboratory next year are threatened by the fear of prospectiv­e staff being sued.

Senior figures in the screening service told journalist­s this week they wanted to “start a conversati­on” because of their worries over the risks posed for women by the “current discourse” about screening.

The concerns they expressed about rising litigation costs, and about women turning to unproven treatments because of a lack of trust in screening, prompted an angry response from the women at the heart of the 2018 controvers­y. Three years on, common ground remains as hard to find as ever.

For seven out of eight women with cervical cancer, the immunother­apy drug pembrolizu­mab “does nothing”, Dr Nóirín Russell, clinical director of the screening service, had pointed out.

Some patients are choosing “weird and wacky stuff” such as vitamin C infusions while turning down “proven, evidence-based medicine and therapies that would lead to cure”, she also told the briefing.

“What a load of s***e,” responded Vicky Phelan from the United States, where she is undergoing experiment­al cancer treatment as part of a clinical drug trial at the National Institutes of Health.

“Am I, and other women, supposed to just accept our fate and choose standard of care treatments because that is all that there is in Ireland,” asked the woman whose court case in 2018 brought the controvers­y to light.

Political row

“Pembro has bought me almost three years of a really good quality of life!! If I had accepted the palliative regime that I was offered in Jan 2018, I would have been dead by the end of 2018,” she tweeted.

Lorraine Walsh, another of the 221+ Patient Support Group of women who were not informed of an audit of their smears, said she was “gutted to see the HSE blaming the women failed by CervicalCh­eck for its failures in the past and now adding their future failures too”.

Separately, a political row broke out during the week when it was claimed, and later denied, that Dr Gabriel Scally had been “dumped” from overseeing the implementa­tion of recommenda­tions he made in a report on the issue.

It was April 2018 when it emerged that for hundreds of women diagnosed with cervical cancer the original results of their smear had been changed on audit and most had not been told.

The issue was investigat­ed by Scally, while the women’s slides were reviewed by UK experts.

His report garnered headlines for its criticism of governance at CervicalCh­eck and the way women were treated during the audit. Yet he found there were no quality issues with the laboratori­es and that standards were in line with other services internatio­nally.

CervicalCh­eck has largely implemente­d his findings, changed its management structures and advanced plans to repatriate most screening from private labs in the United States to a public one in Dublin but, as this week shows, it struggles to escape the legacy of the recent past.

One reason for this is the succession of tragic cases coming through the High Court, pitting women very sick with cervical cancer against the HSE and medical labs in the full glare of publicity. A tribunal to hear claims in private was set up after much delay but has yet to receive any cases and may never get any.

Outside court settlement­s, CervicalCh­eck disputes the perception of widespread negligence.

Every year, 90 women die of cervical cancer, of whom 50 will have had a smear through the programme. “It is not impossible for some of these cases to be due to error but it is not possible for all of them to be due to error,” Russell says.

Most women detected in the screening programme are detected at stage one of the disease, she says, adding that the vast majority of the 221+ group are “well, alive and unlikely to die of their cervical disease”.

Standard

Almost 250 claims have been lodged against CervicalCh­eck. Some 28 have been concluded – 21 by way of settlement or mediation and one by court judgment, while six were not pursued.

The High Court, in a test case taken by the late Ruth Morrissey, set down the standard that should apply in determinin­g negligence.

Screening laboratori­es should have “absolute confidence” in their decision to give a slide the all-clear, it ruled.

This set the bar of proof too high, according to the medical community. According to Dr Russell, there is no easy way to determine error as two experts can give differing views about the same case.

But while experts differ, the public conversati­on regarding CervicalCh­eck remains stuck.

“A view has kind of settled of what happened, and it’s not necessaril­y what did happen,” says CervicalCh­eck chief executive Fiona Murphy. “I guess it’s always the case when there’s a big scandal or crisis, and everyone’s got their own version of the truth.”

Murphy, who took up the job last year after 30 years working in Scotland, says she has seen “nothing like this” before.

“There is a mistrust of the State in Ireland that is different from other countries. There’s an anger I didn’t feel in Scotland, a much wider context of hurt.”

She notes the changing relationsh­ip of women with the Catholic Church and the State, and the financial crash, “which made people incredibly angry”.

The CervicalCh­eck controvers­y “landed at a time when people were already very angry. It could have been something else and it could have been better explained, but that’s complicate­d”.

But Walsh says CervicalCh­eck needs to change its narrative. Its focus on the limitation­s of screening – at a time when a succession of dying women are alleging negligence in the courts – is confusing women, she says, and causing a loss of trust and confidence in the programme.

“They need to acknowledg­e what happened and that women were failed by the system. Only then can they move on and communicat­e the improvemen­ts that have been made.”

Last March, CervicalCh­eck switched from traditiona­l smear testing to more accurate HPV testing, though the public launch had to be deferred due to the pandemic. Ninety per cent of cancers can now be accurately identified.

Had it not been introduced in 2008, 180 women a year would be dying of the disease rather than 90, says Russell. With HPV testing and the HPV vaccine, there is now the chance of eradicatin­g cervical cancer – but only if trust can be fully restored in the screening programme.

‘‘ They need to acknowledg­e what happened and that women were failed by the system. Only then can they move on and communicat­e the improvemen­ts that have been made

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