Tánaiste Simon Coveney has apologised to a woman dying of cervical cancer who was only informed of her diagnosis last year, six years after a smear test was first taken.
Vicky Phelan (48), from Annacotty, Co Limerick, on Wednesday settled a High Court action for €2.5 million against a US laboratory over the 2011 smear test, which wrongly gave her the all-clear.
Cervical Check, the national screening programme, carried out an internal review in 2014 when Ms Phelan’s cancer was diagnosed but she was not informed until last year. Fourteen other women are also understood to have been diagnosed in the 2014 review.
Mr Coveney told the Dáil that a decision had been made to take “a changed approach” that from now on in which patients would be informed of reviews automatically rather than optionally.
He added that there was “an active piece of work going on now to establish if there are other women in the same category”.
The Taoiseach said doctors had a “duty of candour” to tell patients about cases where they have wrongly been given the all-clear.
Speaking to reporters in Leuven, Belgium after the Tánaiste’s apology to Ms Phelan, Leo Varadkar said “patients have a right to know” about false negatives in their treatment.
“Open disclosure has been policy in the health service for a number of years now and for the last couple of months is actually protected in law,” he said. “So if there is a false positive, or a false negative for that matter, I think there’s a duty of candour on doctors and that they should inform the patient as soon as possible.”
Horrific experience
Minister for Health Simon Harris said he had ordered a review of the cervical screening programme to ensure it is operating in accordance with international best practice.
Speaking to reporters at Government Buildings, Mr Harris said he wanted something good to come out of Ms Phelan’s horrific experience. He said action would follow and it would be swift.
Sinn Féin TD Donnchadh Ó Laoghaire told the Dáil it was his understanding that between 2016 and last year there was a year of correspondence over whose responsibility it was to tell Ms Phelan.
“It seems to be the case that in all these incidents the last person to know is the woman affected,” he said, adding that had Ms Phelan’s cancer been detected in 2011, she would have had a 90 per chance of being cured.
Mr Coveney said that anyone who listened to Ms Phelan’s story story or read about it would come to the conclusion that it was “a shameful series of events particularly in relation to information flow and the tragedy and challenges that Vicky Phelan and her family are facing now have been made all the more difficult because of the failings in terms of the passing on of information and for that as Tánaiste I want to apologise to her and her family”.
The fact that information was knowingly withheld from her and her doctors for three years "makes it completely inexplicable and frankly absolutely unacceptable", Fianna Fáil deputy leader Dara Calleary said.
Incorrect results
He said the 2014 smear tests found incorrect results in up to 14 other women but it was only in 2016 that medical consultants were advised to deal with the women and tell them of the results, he said.
The approach taken by Cervical Check has been “cruel and bizarre in the extreme”, the Mayo TD said.
It was “absolutely unbelievable” that doctors were asked to use their own judgment about whether to inform women about the misdiagnosis, particularly when the women were given the all-clear.
He asked the Tánaiste how this was acceptable, medically legally or ethically.
Offering his apology, Mr Coveney said the smear test was not a diagnosis but a screening and it was a “false negative”. He said there was no perfect screening programme and those in CervicalCheck their systems were as good as anywhere in the world and they were open to peer review.
He said that when Ms Phelan was subsequently diagnosed as having cancer, there was an audit as there always is a review of previous tests.
Mr Harris said that since 2016 doctors had been receiving results of audits in relation smear tests of their patients. He said there was a presumption and expectation that they would have conversations subsequently with their patients.
“ In some cases it happened. In some cases it may not have happened,” the Minister said.
Mr Harris said it was essential “that we establish that doctors told their patients of the outcome of those audits”.
“That is why today Cervical Check will today write to those doctors and ask them to confirm that they have informed the patients of the outcomes,” he said. “We can’t just presume that they did . We need to make absolutely sure that they did.”
Automatic
The Minister said that in the future he wanted to ensure it became automatic that women would be informed of the outcome of any audit or review.
Mr Harris said while the Cervical Check screening programme was saving lives, it was necessary for people to have confidence in it He said the screening programme was now 10 years in operation and “it is appropriate that we review it”.
The Irish Cancer Society extended its sympathies and offered its support to Ms Phelan and her family, and other women affected, saying the Phelans had been through “a trying and traumatic experience”.
“A cancer diagnosis is one of the most, if not the most, difficult experiences a person and their family can deal with,” the society said in a statement. “Doing so at a late stage, in the knowledge that you could have been diagnosed earlier is a harrowing experience, and it is saddening to see cancer patients on the steps of the High Court.”
The society said it fully supported and had confidence in the CervicalCheck programme, describing it as a “truly-life saving” initiative.
“This is the best available measure we have at our disposal to detecting cervical cancer early and has helped reduce the cervical cancer rate nationally at a rate of 7 per cent per year. Combined with the HPV vaccine, there is an opportunity to all but eradicate cervical cancer in the decades ahead,” it said.
The society said there were “clear lessons” from Ms Phelan’s case for the HSE and the National Screening Service and that an external review needed to take place “to make sure that processes for communicating information about missed abnormalities or missed diagnoses are put in place, and that the responsibility for who must do that is made absolutely clear.
“This must be a prompt, responsive and unambiguous system, whereby all women are who find themselves in such a situation are communicated with, in line with their expressed wishes.”
