Tuesday May 26, 2020

CervicalCheck probe atmosphere was 'fevered', says Scally

Dr Gabriel Scally has had plenty of brushes with tragedy and scandals during his time as a senior public health doctor in England. But he says nothing compares to the experience of the CervicalCheck debacle, which he was brought in to investigate last year

Susan Mitchell

Deputy Editor and Health Editor

@susmitchellsbp
21st July, 2019
2
Dr Gabriel Scally, pictured at Doughmore beach in west Clare last week Picture: Eamon Ward

Dr Gabriel Scally took a phone call during the first weekend in May 2018 from a senior official in the Department of Health. By the end of the call, he had agreed to carry out a scoping inquiry into Ireland’s controversial CervicalCheck programme. He signed up for six weeks, but the job ultimately lasted for 14 months and took his team as far afield as Texas. It has also made the Belfast-born Scally a household name in the Republic, and certainly the most high-profile doctor in the country.

During the course of his inquiry, Scally made few media appearances, deciding instead to concentrate “on getting the job done”. Earlier this month, he wrote to Minister for Health Simon Harris to say that his work in Ireland was complete.

I interview him in Doonbeg, Co Clare, where he is taking time out to hike, unwind and enjoy the Willie Clancy music festival in Miltown Malbay. Scally had met women and families affected by the CervicalCheck debacle earlier that week. He has held a number of meetings with the over the past 14 months, but this last meeting appears to have been a tough one..

While he has been widely praised for his work, it is clear that some of those directly affected still believe there has been a cover-up, and that the lid was not fully lifted on what transpired under Ireland’s CervicalCheck programme. Scally appears frustrated. He describes some of the questions he received at his last meeting with members of the 221+ cervical check support group. He was asked about possible clusters of mistakes at certain laboratories.

“It might be possible that they’ll find a little cluster of error, but that shouldn’t really happen,” he says, because forms detailing the performance and details of all individual screeners are sent back to CervicalCheck on a regular basis. “I explained all this, and, in my mind it’s all very logical and understandable. But I was absolutely floored by being asked: ‘Well, how do we know they’re telling the truth? How do we know they wrote down the right figures in the forms?’”

Scally describes how, at that same meeting, he was asked how he could be certain that laboratories hadn’t simply skipped the screening of a box of slides and then reported them as normal. “I said: ‘Well, we don’t’. This was nine, ten, eleven years ago. I’ve got no DeLorean [like in] Back to the Future, to take us back there and see what’s going on in the place,” he says.

“Every time I’ve produced a report, someone has always said: ‘But there remain unanswered questions’. Maybe that should be my epitaph on this: there remain unanswered questions, because there always will be unanswered questions.”

***

Scally had plenty of brushes with tragedy and scandal during his time as a senior public health doctor in England. He halted surgery at a paediatric cardiac surgery centre in Bristol when he was director of public health in southwest England. A subsequent investigation concluded that the unit had left 34 children under one year of age, who would have survived in other units, dead. As Scally himself wrote, those deaths and that inquiry “changed the face of British medicine”.

More recently, he was adviser to the chair of the inquiry into hyponatraemia-related deaths in the North. The inquiry concluded that the deaths of four children had been avoidable. It was, he said, a “remarkable account of lies, deceit and cover-up, of negligence and of secrecy and deliberate obstruction”.

For Scally, it was also personal. Some of the doctors involved were “friends” of his and some had trained with him when he studied medicine at Queen’s University Belfast. And yet, of all the inquiries he has led, supported or initiated, he has “never seen anything like” the CervicalCheck debacle.

“This one was really quite remarkable, or remarkably different,” he says, adding that it was particularly emotional. While he says he could understand why women and their families were “so emotional” (see explainer panel), the atmosphere “was really very unusual. Typically, when one of these things happen that I’ve been involved in, either in the North or in England, there’s a really serious problem identified and it’s decided there’ll be an investigation into it, or an inquiry. And usually there’s a pause. The pause button is pushed and people wait to see the outcome of the inquiry.”

With CervicalCheck, he says, “it hasn’t been really like that at any stage”. Instead it has been “fevered” and dogged by misinformation. At times, Scally found it difficult to access key personnel for his inquiry. He was trying to talk to people and “couldn’t get hold of them because they either were appearing before one of the committees of the Oireachtas or the PAC [Public Accounts Committee]”, or were preparing to appear before politicians.

This “toxic mixture of politics, media and law” was an “impediment” to him. But he also feels it was “unhealthy” and led to “snap judgments, erroneous facts and some very wild statements from a lot of people which were most, most unhelpful”.

Scally references one false claim in particular that clearly incensed him: that women would have been treated earlier for cancer, or differently, had the audits been disclosed to them. That was, he says, hugely painful for those directly affected – and also confusing.

“When women read that or hear that, who are they to believe? Are they to believe these prominent public figures who make these absolutely inaccurate statements, or are they to believe the letter they’ve had from the HSE?” he asks.

“During that fevered period when all these misleading claims were made, there were very few – I thought – really senior doctors standing up and explaining it, and it just wasn’t good enough. So this was left to play out.”

The chaos led to mistakes being made. I ask Scally about the free (out-of-cycle)smear test offer made by the government, which critics felt fuelled public panic. “If I had been asked for my advice about the free smear test, I would have said it was not a good idea. But I wouldn’t criticise the taking of the decision because I think the situation was unparalleled and unique. These were not normal times.”

He was astounded by “the rush to judgment” and clamour for heads to roll. The frenzied environment resulted in the former clinical director of CervicalCheck losing her job. It also resulted in the former director-general of the HSE, Tony O’Brien, departing early.

Was that fair?

“A headlong rush to identify someone who can be blamed rarely ends well,” Scally replies.

Dr Gabriel Scally: ‘Maybe my epitaph on this should be: there remain unanswered questions and there always will be’ Picture: Eamon Ward

“Some of the political public discourse here seemed to be focused on the rapid identification of who did wrong before the facts were established. I don’t know whether that’s the norm in the Republic, whether that’s the way the system works or not. But the net effect of it is not helpful. It’s not helpful in moving things on. It’s not helpful in finding the facts. It’s not helpful in getting to the bottom of things.

“I don’t think you can have a proper discourse, really, about something as complicated and difficult as this without getting to the facts first. But there was a sudden rush to judgment and a sudden search for people to blame and for people’s heads to roll. And I heard that phrase used very often – whose head is going to roll for this? As if that makes it go away, or makes the issue go away. The issue is still there, and still needs to be explored and rationally dealt with.”

There were two strands to the CervicalCheck debacle. One was the failure to disclose the results of retrosepctive test reviews to women. This happened as follows: after women were diagnosed with cervical cancer, the health service decided to audit any previous screening tests they had.

The aim of the audit was “laudable”, as Scally says, but when discrepancies were found the results of the audit were not disclosed to women affected. The health service was accused of a deliberate, orchestrated cover-up.

The second strand pertained to why the original screener did not spot abnormalities on the slide. While this is not uncommon in screening, as there are known limitations to screening, many feared that the labs were making mistakes that should not have happened. In other words, the accusation levelled at the time was that the labs were missing abnormalities that better labs would have spotted.

Scally’s scoping inquiry was published last September. It found no evidence of a cover-up or any evidence that the laboratories currently used by Ireland’s screening programme were substandard. But he did conclude that governance was poor and that the programme was doomed to fail. He also found that laboratories contracted by the health service had outsourced work without the knowledge of health service management.

The report was widely praised, as was Scally. He was credited with bringing clarity to what was a very complex and hugely fraught issue. He was also praised by those directly affected for dealing with them with grace and compassion.

Scally was very critical of members of the medical profession in his report. he said that while some disclosures were well handled, the way in which some women were told about the audits was terrible. Some doctors behaved very badly when disclosing sensitive information to women and families affected, he said.

Scally was very critical of members of the medical profession in his report. He said that while some disclosures were well handled, the way in which some women were told about the audit was terrible.

Doctors, for their part, felt Scally failed to outline some important facts. There was criticism that Scally did not provide information on the stage at which women were diagnosed: his report did not clarify whether most of the women affected had been diagnosed with stage four terminal cancer, or with early stage cancers. There is a huge difference in respect of the prognosis and outcomes.

That information was belatedly provided by the HSE earlier this year, when it finally disclosed that 158 of the 221 women affected were diagnosed with pre-cancer or early-stage cancer. We also now know that the majority (178, or 80 per cent) were reported by their treating clinician earlier this year to now have no evidence of active disease. While that news was very welcome, some of those women still underwent gruelling treatment regimes to treat their previous cancers.

Doctors also criticised Scally for not providing information about the nature of the category change on review. Was there a significant category change or not? We stil don’t know, although the fact that so many women were diagnosed at an early stage suggests not. Doctors warned that the failure to put these facts into the public domain allowed a widespread perception to develop that most of the 221 women had advanced cervical cancer.

Scally says he did “not have access to individual clinical data”. The task of examining individual slides was given to the Royal College of Obstetricians and Gynaecologists (RCOG) which still hasn’t completed its work - to the frustration of many.

Privately, doctors accused Scally of depriving them of an opportunity to respond to some of the comments they were said to have made. He strongly refutes this.

“I met with colposcopists [the doctors who examine the cervix] and I read out the quotes to them. At no point did anyone question the veracity of them,” he says. “The same account was given by different women and families. The words used were deeply imprinted on their memories.”

The doctors’ comments highlighted by Scally outraged the public. Taoiseach Leo Varadkar, who trained as a doctor, said some of the personal testimonies in the report made him “embarrassed” for his own profession.

“One of the most disturbing accounts was relayed by the close relatives of one of the women who is deceased. As part of the disclosure meeting, the consultant mentioned several times that the late woman was a smoker [it is known that smoking impedes the body’s ability to clear itself of the HPV virus] and they were told that ‘nuns don’t get cancer’,” the report stated.

Scally says it was “verging on misogynist”, the inference being that “if women had behaved themselves it wouldn’t happen to them. It lines up with the use of the word hysteria”.

***

The word “hysterical” was used by high-profile solicitor Cian O’Carroll and Mr Justice Kevin Cross when describing the reaction from medics to a recent ruling in the high-profile case taken by Ruth Morrissey in the High Court.

“It’s a highly gendered term,” Scally says, adding that he has concerns about the Cross judgment.

“Legal brains like absolute confidence: nice and cut and dried. But medicine isn’t like that,” he warns. “If I came across a consultant treating me or my family who was talking about absolute confidence, I’d worry about that. I want a doctor who thinks about all of the options and keeps the mind open, and is always considering and reconsidering.

“I don’t like absolute confidence. Neither do I like the introduction of a principle, which may grossly affect an overall screening programme, arising from one case.

“There is a legal saying: hard cases make for bad law. And there’s nothing harder than the cases of these women. Nothing. Nothing harder. But screening programmes are about balance.”

He adds that over-investigation and overtreatment are damaging.

“I don’t believe there is absolute confidence. Secondly, there always will be human error. And we know that. So as long as there are screeners looking down microscopes or pathologists looking down microscopes or looking at mammograms, there will be errors.”

In his most recent supplementary report, Scally also took aim at an element of Mr Justice Kevin Cross’s judgment in the Morrissey case.

In his judgment, Cross stated: “The HSE organises follow-up tests on a periodic basis every three years for persons of the plaintiff’s age. In the United States, the follow-up period for rescreening was every year. As HPV vaccination came to be used in the United States, the follow-up period for screening has been gradually extended to first two and now it is in some cases every three years.”

Scally contradicted this, saying: “The issue of how frequently cervical screening should occur has been raised, with many references to annual cervical screening in the US.

“The US did at one time have a general approach of annual cervical smears, but that was before the introduction of organised screening programmes. The official US policy is now, and has been for some time, for cervical screening to be carried out at a three-year or five-year interval.

“This is not to do with the introduction of HPV vaccination, as has been erroneously stated, but because of the harm resulting from annual smears.”

While Scally believes that patients who have been damaged by the system deserve to be compensated, he also feels the medico-legal environment in Ireland is “a problem”.

“Settlements are higher, litigation is more likely and the law, or the operation of the legal process, is more antiquated,” he says.

He refers to the use of shared evidence in England which, he says, “has been a major step forward”.

In the Republic, he explains, what happens is that “legal teams go hunting for experts to give them an opinion that strengthens their case” and so does the other side.

Ultimately, it ends up being a “gladiatorial exercise in front of a judge. And part of the problem is that the judge has no ability to independently inquire into the rights or wrongs of the case. Judges can only rely upon the experts and the evidence that’s put before him or her. And that’s what they’re judging it on. So, therefore, it’s a very, very poor way of responding to error”.

Scally speaks about “phenomenally brave women like Vicky Phelan and Ruth Morrissey, who clearly have been resourceful enough and tough enough to go through that and come out the other end, despite what’s happening to them physically and no doubt psychologically as well.

“Not all women are built for that or want that, or can cope with it.”

***

Scally has finished his investigative work on CervicalCheck, although he will report on how his recommendations are implemented.

It was, he says, “a huge privilege and honour” to do this work, but he is “relieved” that it is over and that he can “return to normality”.

He is not confident that the review carried out into individual slides by the Royal College of Obstetricians and Gynaecologists (RCOG) will yield any significant new information. Many of the women and families affected have not agreed to participate.

Scally is also not optimistic that Mr Justice Charles Meenan, who has been tasked with considering an alternative mechanism to the court process for resolving clinical negligence claims, will come up with any radical departure from the status quo.

Does Scally believe that the Irish health service will ultimately be better and wiser after the CervicalCheck debacle?

“The Irish health service will be better if the lessons from CervicalCheck on issues such as clear lines of managerial, professional and financial accountability, openness, development of public health expertise, and involvement of patient advocates are applied widely,” he says.

“Given the level of cultural change needed, that can only be done with committed, expertise and compassionate leadership. Failure to drive change throughout the system should not be contemplated.”

Timeline: how the CervicalCheck debacle unfolded

April 25, 2018: Vicky Phelan breaks down outside the High Court in Dublin after receiving a €2.5 million settlement in her action against a US laboratory for misreading her cervical smear test.

She found out that CervicalCheck had initiated a review of her previous screening history after she was diagnosed with cervical cancer in 2014. That review concluded that an earlier smear test was what is called a false negative. Phelan’s doctor was told in 2016, but she was not told for another year. She described it as “an appalling breach of trust”.

April 26, 2018: there is a public outcry when heavily redacted documents reveal that more women who had been diagnosed with cervical cancer had also had previous test results reviewed. On review, it was determined that their tests could have provided a different result. Like Phelan, many were not told.

We now know that there were approximately 221 women who had been diagnosed with cervical cancer whose cytology tests – on review – were revised. These earlier screening tests were reviewed retrospectively after the women were diagnosed with cervical cancer.

April 28, 2018: Professor Gráinne Flannelly, the clinical director of CervicalCheck, stands down.

May 5, 2018: HSE director general Tony O’Brien resigns.

May 8, 2018: the cabinet agrees to establish a scoping inquiry into the issues that have come to light in CervicalCheck. Dr Gabriel Scally is appointed to lead the inquiry. The government also announces that an international expert panel will independently review the screening results of all women who have developed cervical cancer and participated in the screening programme.

June 29, 2018: Emma Mhic Mhathúna, who has terminal cancer, settles her case against the HSE and a US lab for €7.5 million. She dies in October.

August 1, 2018: the government announces that Mr Justice Charles Meenan has been asked to identify mechanisms to avoid adversarial court proceedings for women affected by the CervicalCheck debacle.

September 12, 2018: Scally’s report into CervicalCheck finds significant failures in the governance structures of CervicalCheck.

October 16, 2018: Judge Meenan recommends that a Tribunal is established.

May 3, 2019: terminally ill Ruth Morrissey and her husband Paul, who have sued over her CervicalCheck smear tests, are awarded €2.1 million by the High Court in her landmark action. Justice Kevin Cross rules that screeners must have “absolute confidence” in test results. The labs and the state are appealing the ruling.

June 11, 2019: Scally’s supplementary report sheds further light on the extent to which smear tests were outsourced to unapproved laboratories by the private companies that carry out most of the screening work for CervicalCheck.

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