Scally report contrasts with political hysteria of early scandal

Claims of some politicians misleading and potentially damaging to a screening programme

Sinn Féin leader Mary Lou McDonald told the Dáil that “women were literally allowed to die before fault was admitted”. Photograph: Cyril Byrne/The Irish Times

Sinn Féin leader Mary Lou McDonald told the Dáil that “women were literally allowed to die before fault was admitted”. Photograph: Cyril Byrne/The Irish Times

 

The Scally report, published on Wednesday, was a measured account of a profound failure by the State’s health services.

But its conclusions demonstrated that the claims made by some politicians when the scandal first emerged in the spring were at best hyperbolic, certainly misleading and potentially damaging to a programme that has saved many women’s lives.

The best that can be said of it is that some politicians lost their heads and the media reporting of that process was recklessly alarmist.

The Scally report laid bare alarming failures by the medical profession and the State’s health services to treat women with respect and compassion. Information about their medical history was withheld by the screening service and by doctors. In some cases, when it was communicated, the process was done with ignorance and callousness.

But what the report also found was that the scandal – and it is a scandal – was the failure by CervicalCheck and their doctors to notify women about audits of their past smears. It was a failure of management, organisation and communications. It did not find that the screening process itself was flawed.

In fact, Scally went to great lengths to defend the screening process and seek to reinforce public confidence in it, finding that there was no evidence of any reasons for concern about the laboratories which examine the smears.

“I am satisfied with the quality management processes in the current laboratory sites ie. CWIUH, Quest, and the Sonic Healthcare Laboratories, namely MLP and TDL. I am also satisfied that the quality management processes were adequate in the former provider, CPL in Austin, Texas, part of Sonic Healthcare,” the Scally report said.

He is continuing to investigate the outsourcing by CPL of some Irish screening from Austin to five other locations.

Scally heard the testimonies of many women. But he did not examine the individual medical evidence in each case; that is the subject of a separate review being carried out by the Royal College of Obstetricians and Gynaecologists, which will not be completed for many months.

‘Care is needed’

But in his report Scally sought to explain that it wasn’t as simple as it might seem when smear tests do not return indications that cancer might be present. It’s complex but worth understanding: “Tests results are often referred to as being positive and negative. The terms ‘true’ and ‘false’ are sometimes attached to the result. But great care is needed in the use of these terms as they may be applied in different ways,” Scally warns.

He went on to talk about the difficulty of reviewing smear tests where it is already known that cancer is present – this is clearly not the same as looking at smears without that knowledge.

“In the context of retrospectively reviewing slides in cases where there is a definite cancer diagnosis confirmed by histology, true negatives are samples which genuinely have no abnormal cells on them, despite the presence of disease.

“False negatives are those where the slide was originally reported as negative but on review abnormal cells are found. Some screening programmes then divide those false negatives into one of two groups: 1. Abnormalities that most screeners would not have detected. 2. Abnormalities that most screeners would have detected.

“It is often a matter for professional judgement and discussion into which of these two groups any single false negative will fit,” Scally says.

The report made no judgment about which category the smear tests of the 221 women caught up in the debacle would fit into.

That would be a matter for individual clinical review. But it is clear that even if some of the women’s smears (as they surely will) contained abnormalities that “most screeners would have detected”, this is not evidence that the entire programme is defective. This is simply the nature of screening which will always have an unavoidable error rate.

Savage attacks

The report states: “it is estimated that cervical screening prevents 75 per cent of invasive cervical cancers by detecting and treating cervical abnormalities that, if left, would place patients at high risk of developing invasive cervical cancer”.

That is no consolation to the women diagnosed with cancer, but it is a fact. Cancer’s odds are always cruel.

Dr Scally’s compassion for the women is evident in his report. But so is his rationality and evidence-based approach. The latter was not, to put it mildly, a feature of public debate when the scandal arose.

Politicians tripped over each other in a rush to make the most scathing denunciation of the HSE and its boss Tony O’Brien, the most savage political attack, the direst warnings about the screening programme. Women all over Ireland are terrified, they warned. It was no wonder.

But many of the most blood-curdling warnings were based on the erroneous precept that the delay in informing the women about audit test results had an effect on their cancer treatment. This was completely false: the only reason their smears had been audited was because they had been diagnosed with cancer.

Of course, as the report says, had the original smears been read differently, they could potentially have been diagnosed and potentially treated earlier. But the delay in informing women had no effect on their treatment.

One of the chief offenders was the Sinn Féin leader Mary Lou McDonald.

“Women’s lives were put in jeopardy by the HSE withholding information on false negative smears with the women,” she tweeted on May 8th. This was untrue.

In the Dáil on May 2nd, McDonald warned that the HSE had been withholding “vital information – life and death information”.

“This controversy is not simply a case of catastrophic dysfunction; it is a case study of deceit of the gravest nature,” McDonald warned.

After diagnosis

A day earlier, she said that “for some of the women affected by the scandal there will be no telephone call, no news, no disclosure and no truth because 17 of them are dead. They passed away not knowing that their cancer should have been caught earlier, that their treatment programmes, prognosis and possibly outcomes could have been different . . . women were literally allowed to die before fault was admitted”.

On May 9th, McDonald told the Dáil: “We cannot with all certainty state whether in each case the withholding of that information had a material affect in diagnosis and subsequent treatment.”

This was demonstrably untrue. The withholding of information could not have affected diagnosis or treatment, because it came after diagnosis and treatment.

The “playing with people’s lives” motif surfaced frequently. At a highly charged meeting of the public accounts committee, the Fianna Fáil TD Marc McSharry declared, “the reality is that we have had gross systemic failure and that people are dying”.

McSharry went on to say: “We understand that screening gives indications. When one gets an indication of something that requires further scrutiny, one is referred on. The people who chose whether to communicate or not communicate the information made a decision not to do so. Those people, who are clinicians, were playing with people’s lives in not so communicating”.

The independent TD Joan Collins told the Dáil: “The fact of the matter is we have women dying here because their screening was not tested adequately”.

There were many more examples, both in politics and in the media coverage, of alarmist confusion, either wilful or otherwise. The difference between diagnosis and screening was roundly ignored.

“How many more women were misdiagnosed?” screamed one Daily Mail headline. “Anguish of the mother sentenced to death by a smear test blunder.”

Another in the Examiner in May said: “How many more must die before we get to the truth?”

The Scally report made 50 recommendations. It also contained many more lessons. One of these might be that when the political and media temperature is at boiling point because of the latest scandal, it might be wise for all concerned to take a deep breath, consult the experts, and take another look at the facts. No matter how tragic and powerful the circumstances may be.