Life Health & Wellbeing

Friday 24 May 2019

One year on: just how safe is our cervical cancer screening?

The big read: The CervicalCheck scandal has eased, but have lessons been learned, asks health correspondent Eilish O'Regan

Influential: Vicky Phelan speaks to the media after meeting the Taoiseach at Government Buidlings last August. Photo by Eamonn Farrell
Influential: Vicky Phelan speaks to the media after meeting the Taoiseach at Government Buidlings last August. Photo by Eamonn Farrell
Campaigner: Stephen Teap. Photo: Gareth Chaney
Emma Mhic Mhathuna. Photo: Steve Humphreys
Investigator: Dr Gabriel Scally. Photo: Frank Mc Grath
Crisis: Varadkar and Harris. Photo: Frank Mc Grath
Tony O'Brien.
Ruth Morrissey
Eilish O'Regan

Eilish O'Regan

This time last year, a giant wave of panic and fear that would not subside for many weeks was about to engulf the country.

Women who had been diagnosed with cervical cancer were in the dark about internal reports from CervicalCheck, the national programme for cervical cancer screening, showing they got a wrong smear test result. The revelation caused widespread dread and anxiety.

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Public confidence in CervicalCheck was shaken. The most profound and moving impact was heard in the anguished interviews with women suffering from the cancer, many of whom had young children.

So what have we learned? Was it a scandal or a crisis? And how safe is CervicalCheck now?

Emma Mhic Mhathuna. Photo: Steve Humphreys
Emma Mhic Mhathuna. Photo: Steve Humphreys

Here's a detailed overview of what we have learned, and what we still don't know:

Q The failure to disclose these look-back audits of the test results of other women with cervical cancer unfolded gradually. So why was the information difficult to get?

A We know today that 221 women were affected. But establishing that was a tortuous process. It took many weeks involving HSE teams investigating files and acrimonious appearances by health officials before Dáil committees before the full truth emerged. These audits of women's test results were carried out after they were diagnosed with cervical cancer and CervicalCheck was informed of their cases. So not knowing about the audit would not have affected their prognosis.

But the drip-drip approach to releasing information over a long, hot summer and the dramatic scenes before the Public Accounts Committee meant the sense of public fear and anger was unabated.

Q Was it not the case that many people had the mistaken belief that the audits were done before the women developed cancer and they were kept from them?

A There was some confusion about that, but it was made clear early on and many times by journalists covering this that the audits happened after the cancer was found.

Campaigner: Stephen Teap. Photo: Gareth Chaney
Campaigner: Stephen Teap. Photo: Gareth Chaney

These audits nevertheless are crucial pieces of personal medical information for the women involved and also for the bereaved families of those who died.

The audits say the women received wrong smear test results. In some cases, several tests were incorrect going back a number of years.

They throw light on how - despite going for regular screening - the women still went on to develop cervical cancer. These women would have agonised about what went wrong. They had a basic right to know. This applies to all patients.

In the case of Emma Mhic Mhathúna, the Dingle-based mother of five who tragically died of cervical cancer last autumn, it meant she could get her tests independently assessed. She received a High Court settlement of €7.5m which provided for her young family after losing their beloved mother. It was only after Limerick mother of two Vicky Phelan highlighted the issue that Emma was told of her audit.

Q Was there a clear onus on CervicalCheck to tell them about the audits?

A The HSE has a policy of open disclosure since 2013, which should mean patients are told if mistakes have been made in their care. Dr Gabriel Scally, who investigated CervicalCheck, described this HSE policy as flawed. It was a voluntary system. In the case of most of the 221 women, the HSE decided in 2015 that the audits of the tests should be given to the women's treating doctors and passed on to the women "as appropriate".

CervicalCheck under its then clinical director Dr Gráinne Flannelly told doctors in July 2016 that audit results should be added to the woman's file.

It said that as a "general rule of thumb" the woman should be told, but doctors could "use their judgment in selected cases where it is clear that discussion of the outcomes of the review could do more harm than good". If a woman died, it could be just recorded in her notes.

Q How many had not been told about the audits?

A We now know the majority of women or bereaved families were not informed until the scandal became public. The manner in which they were told last summer varied from "unsatisfactory and inappropriate to damaging, hurtful and offensive," said CervicalCheck investigator Dr Gabriel Scally.

When one woman tried to question her oncologist further on what open disclosure meant, the consultant "shut down, refused to answer the simplest of questions and ushered me out the door with no support".

Worryingly, look-back audits on more women who develop cervical cancer have been stalled since last year and will not resume until a new system is agreed.

Q How much have we learned about cervical screening? Was the failure due to negligence?

A A wrong smear test result does not necessarily mean there has been negligence. Some abnormalities are missed because of a lack of proper care but others cannot be seen in the laboratory because of the limitations of screening. This is nobody's fault. CervicalCheck now sends an improved information booklet to women about the limitations of its service. It says that for every 1,000 women screened, 20 will have abnormal cervical cells. Some 15 of these women will have the abnormalities picked up but five will not and may develop cervical cancer.

Q Are Irish women at greater risk of a wrong test result because screening is outsourced to labs here and the US?

A No. There is no evidence of that, said Dr Scally. He said he was satisfied, based on his examination, with the quality in the current labs used by CervicalCheck and he said women should continue to use CervicalCheck. They are Quest Diagnostics in New Jersey, MedLab in Dublin and the Coombe hospital lab, Dublin. He said he was also satisfied with another lab used up to 2013 operated by CPL in Austin, Texas.

Q How many women whose tests showed cervical abnormalities were picked up by CervicalCheck screening over the past decade?

A Around 65,000 women who went for a test were found to need further examination. CervicalCheck has saved lives, too.

Q What of the other labs the Irish tests were sent to?

A Dr Scally is to deliver another report shortly on labs which were used and which CervicalCheck says it was not told about. This was done to offload pressure on the main labs. They are in Las Vegas, San Antonio and Victoria, Texas and Honolulu, Hawaii. Other locations have also emerged including Wyoming. He has visited these labs which examined thousands of tests from Ireland and will give his verdict shortly.

Q But are there not other layers of information about the labs used by CervicalCheck which also need to be filled out?

A Yes. An independent review by experts from the Royal College of Obstetricians and Gynaecologists is due this summer. It is the first in-depth look at the labs and involves a review of 1,766 women's slides. This should give information on any weaknesses in the analysis of tests from women who used CervicalCheck and went on to develop cancer as well as patterns of differences between the labs.

Q A decision was made on April 28 last year to offer a free repeat smear test to any woman who wanted one? Was this wise?

A At the time there was huge anxiety among women who were contacting GPs and asking for tests. Health Minister Simon Harris said an offer of a free test and prior consultation with the woman's GP was the only compassionate response at the time. It was not fair that only women who could afford a private test could have one. He has since come under strong questioning from Fianna Fáil spokesman on health, Stephen Donnelly, on the level of advice he had in favour and against this decision.

The minister has insisted the move was consistent with the advice of Chief Medical Officer Tony Holohan.

Q How alarming is the backlog of tests and delays in women getting results?

A There are around 80,000 tests in the backlog with delays of up to 33 weeks from one lab. The HSE is currently in talks on finding extra labs and hopes to finally clear the backlog by the summer.

However, the HSE says the natural history of cervical cancer would indicate that the disease would normally develop over a period of 10 to 15 years. A period of up to 33 weeks for the return of cervical screening results, "while undesirable, poses a very low risk to women".

Stephen Teap, the Cork father of two young sons who lost his wife, Irene, to the cancer, said there is an ongoing need to "restore trust and save lives". Clearing the backlog, ensuring women who are referred for examination are seen on time in clinics and the move to HPV screening in labs are among his priorities.

Q At what stage are plans to introduce HPV testing of slides in labs to reduce the risk of abnormalities being missed?

A It was due last October but preparatory work is under way and it is likely to happen at the end of this year or early 2020.

Q Has anyone been held accountable in the HSE or CervicalCheck?

A No. An internal disciplinary review was set up last year but is still under way. Dr Scally said it was "a whole system failure" and did not single out any individual for blame.

Q Who is running CervicalCheck now?

A A new interim national director of screening - Damien McCallion - has been appointed. CervicalCheck has a new clinical director, Dr Lorraine Doherty. For the first time it has appointed a director of public health and a CervicalCheck laboratory quality assurance lead.

A risk committee, which is independently chaired, was put in place last year. There is still a lot of ground to make up and Dr Scally is doing three-monthly checks on the progress of his recommendations.

Q How long more will CervicalCheck be reliant on outsourcing to labs?

A This will continue for some years. The plan is to develop a national cervical screening laboratory at the Coombe hospital but it will be some time before there are enough qualified staff.

Q What has happened to the 221 women who were caught up in the scandal?

A Tragically, 21 have died. Most are cancer-free although many continue to suffer side effects. Eighteen are still in treatment.

Q Has anything good come from all of this?

A Hopefully it will lead to a better screening service. Women are certainly more aware both of the risks of cervical cancer and the limitations of screening.

Around 26,000 women who were not registered with CervicalCheck availed of the repeat test.

And the publicity has had a positive effect on the uptake of the HPV vaccine among teenage girls as the serious implications of cervical cancer have been shown.

 

A timeline of the CervicalCheck crisis

2019-04-13_lif_49470555_I1.JPG
Crisis: Varadkar and Harris. Photo: Frank Mc Grath
 

2008: CervicalCheck is set up as a national cervical screening programme. Free cervical screening will be offered by invitation to women aged 25 to 60. The National Screening Service gives the contract to analyse around 300,000 Irish smear tests a year to US firm Quest Diagnostics.

2010: Clinical Pathology Laboratories, based in Austin, Texas wins the contract to provide laboratory services for CervicalCheck.

2013: The Health Service Executive introduces a policy of open disclosure, promising honest communication to patients.

2015: CervicalCheck reviews an internal look-back audit it carried out on the smear test results of a number of women who it was told had been diagnosed with cancer. In 2016 it releases the audit, showing the women received wrong test results, to their doctors. The advice is women should be informed "as a general rule of thumb", but doctors should "use their judgment".

April 25, 2018: Limerick mother of two Vicky Phelan settles her High Court action against Clinical Pathology Laboratories for €2.5m with no admission of liability. Ms Phelan, who had advanced cancer, only found out about the audit of her tests in 2017 although it was carried out in 2014. On the steps of the Four Courts she speaks of an "appalling breach of trust".

April 26, 2018: Redacted documents from CervicalCheck, obtained in Vicky Phelan's legal case, causes a public outcry. It shows more women diagnosed with cancer had their tests audited and they were found to be wrong but they were not told.

April 28, 2018: A helpline has to be set up to deal with concerned women. In a weekend, it receives more than 2,000 calls. Health Minister Simon Harris announces any women who wants a repeat smear test will get one for free. Prof Gráinne Flannelly resigns as clinical director of CervicalCheck.

2019-04-13_lif_49470280_I2.JPG
Tony O'Brien.

May 5, 2018: Tony O'Brien (above), director general of the HSE, resigns.

May 8, 2018: The Cabinet agrees to set up a scoping inquiry into the crisis and appoints Belfast-born former UK public health doctor Dr Gabriel Scally to conduct it. An international group of experts will carry out a review of the quality of labs used by CervicalCheck.

May 22, 2018: Taoiseach Leo Varadkar promises mediation "so that women can avoid the trauma of going to court". He said the State will settle with women and then pursue the laboratories. On July 30 he clarifies, saying everyone has the right to go to court and that no government could or should seek to take that right away.

July 5, 2018: The HSE confirms that the number of women whose CervicalCheck tests were audited is 221.

June 29, 2018: Emma Mhic Mhathúna (37), a mother of five living in Dingle, settles her case for €7.5m. She had three tests in 2010, 2011 and 2013, which were incorrectly reported. The 2010 and 2013 slides were both misread. She was diagnosed with cervical cancer in 2016. She sued the US lab Quest Diagnostics.

2019-04-13_lif_49470544_I3.png
Ruth Morrissey

July 27, 2018: Ruth Morrissey (37, right) a mother with cervical cancer from Monaleen, Co Limerick sues the HSE and labs Quest Diagnostics and MedLab. She ends up fighting her case in open court; the case is due for judgment next month.

September 2018: Scally releases a scathing report into CervicalCheck.

He says the screening service was poorly run and doomed to failure, but he sees no reason why CervicalCheck should not continue to use its existing laboratories.

September 2018: CervicalCheck finds out hundreds of Irish women's smear tests were outsourced to labs in Hawaii, Las Vegas and Florida without its knowledge. Dr Scally is commissioned to do another investigation.

October 2018: The 221+ patient support group is founded to support families affected.

October 7, 2018: Emma Mhic Mhathúna dies. Eight hundred people attend her funeral Mass.

October 16, 2018: Judge Charles Meenan recommends the setting up of a compensation tribunal where women seeking damages for alleged negligence can take their case in private. This will not be in place until later this year.

January 2019: Concern grows about the backlog of smear tests which are taking months to be returned to women. More than 70,000 women are facing delays.

March 2019: Scally publishes a progress review of his September report recommendations.

He is satisfied headway is being made but says the HSE's flawed open disclosure policy is still in place. New legislation is due to make this mandatory.

March 2019: An ex gratia scheme is being set up to compensate women who were not told of audit results.

April 2019: HSE says it has found labs to help clear the backlog by this summer.

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