What's the truth behind the cervical smear test scandal in Ireland? Was it a cover-up or simply a flaw in the system? The reality is it's too late for some answers.
For the past two weeks the news in Ireland has been dominated by what is now being referred to across the media here as "the national cervical cancer scandal."
At the center of this has been the case of Limerick woman Vicky Phelan who had been given the all clear after a cervical smear test in 2011 but went on to develop cancer. Making this even worse was her discovery that the error in assessing her 2011 smear test had been identified in 2014 but this had been concealed from her.
She did not learn the truth until last year, three years later, and six years after the original mistake was made. It raised the worrying prospect that the same thing may have happened to many other women here who had developed cervical cancer. This led to the national outcry over the past two weeks.
The details of Phelan's case became public two weeks ago when she settled a court action against a U.S. laboratory which had been contracted to analyze smear tests for the national CervicalCheck cancer program in Ireland. The lab misread her smear test, giving her the all clear, but she went on to develop cancer and, tragically, is now terminal.
The furor which followed both the case itself and Phelan's revelations about the failure to tell her of the misreading in 2011 has been given massive coverage by the media here over the past two weeks in a way that has been misleading and irresponsible. It has caused great anxiety to women across the country and seriously undermined confidence in the national CervicalCheck program which is damaging and dangerous.
Emotive reporting in the past two weeks frequently implied or even stated that Phelan -- and possibly many other women here -- had missed the chance to get life-saving treatment in time due to "a cover-up." That is completely false.
Cervical smear analysis is not perfect and an error rate of an average 20 percent -- giving a false negative -- is the norm internationally. Smears are analyzed for the very earliest signs of cell abnormality, a difficult task which can produce incorrect results. That is why women have regular smear tests.
In Ireland women are encouraged to have a test every three years under the free national CervicalCheck program. The accuracy of the smear testing program in Ireland is similar to that in the U.K., France, Germany and other countries in Europe.
Irene Teap died of cervical cancer last July, not knowing that her previous smears were incorrect. Her husband says their sons, aged 3 and 5 miss their mother. Oscar (5) said: 'I want my Mammy. I just love her so much, I want her back.' https://t.co/BqxA16P9kT— TheJournal.ie (@thejournal_ie) May 8, 2018
Having been wrongly given the all clear after her 2011 smear test, Phelan had her next regular smear test three years later in 2014. This indicated that she had cell abnormality and might be developing cervical cancer.
Further testing that year confirmed this, after which she began her cancer treatment. She only found out about the 2011 error while looking through her file which had been left near her when she was in hospital in September 2017.
It is true that the error in reading Phelan's 2011 smear meant that she missed the chance of early treatment at that point. Sadly for her, she was one of the unfortunate women who get an all clear in error.
But it is not true that there was any delay in her treatment when her 2014 smear test revealed that she was developing cancer. The fact that she was not told then about the error in 2011 did not delay her treatment.
The 2011 mistake was picked up by an accuracy audit carried out by CervicalCheck in 2014 when they re-examined the smear tests of women here like Phelan who had been given the all clear after their 2011 smear test but were found in their 2014 test to be developing cancer. Their 2011 tests were re-examined exhaustively to see if anything that should have been spotted at that time had been missed.
As CervicalCheck has explained, this accuracy audit is done to try to improve the way smear tests are analyzed and to learn from any mistakes. Knowing that this cohort of women subsequently developed cancer means that the original smear tests can be examined with the knowledge that some cell abnormality may be there which had been missed.
In the case of Phelan and just over 200 other women, an error was found. That is tragic for those women but it must be seen in the context of CervicalCheck carrying out over 300,000 cervical cancer smear tests here every year.
Since the program began in 2008, over 50,000 women have been found who had either pre-cancerous cell abnormality or very early stage cancer and were given treatment, saving the lives of the vast majority of them.
Of course it is unacceptable that the error in reading Phelan's smear test in 2011 was not immediately communicated to her when it was discovered in the 2014 audit. But by then she had already started treatment for her cancer.
The suggestion that the failure to tell her about the 2011 error meant any delay in treatment when her cancer was detected in 2014 is simply false. She should have been told -- not least because CervicalCheck is supposed to have a policy of full disclosure -- but this did not lead to any delay in her treatment.
The failure to tell her appears to have been due partly to bureaucratic bungling and partly to uncertainty about whose job it was to inform her of the 2011 mistake. CervicalCheck appears to have taken the view that the correct procedure was for it to tell her doctor and for the doctor to tell her in a way that would be appropriate and would not cause additional anguish. This applied not just to Phelan but to the 208 other women who had got an all clear in error in 2011.
Obviously there are good reasons why CervicalCheck would adopt such a policy. However, there was clearly an onus on CervicalCheck to be sure that the doctors of the women involved passed on the information.
Not doing so, as appears to be the case, is clearly a failure by CervicalCheck and the Health Service Executive (HSE), the overall body which runs public health services here, to operate their own open disclosure policy. Open disclosure of all mistakes in health services, not just in cancer, has been HSE policy since 2013.
Whatever was going on, we do know that in 2016 CervicalCheck made a decision to inform the women involved of the errors made in the 2011 smear tests analysis and uncovered in the 2014 audit. It appears that this information was to be passed on via the doctors of the women involved.
CervicalCheck informed Phelan’s doctor in 2016 about the mistake, but he was unhappy about being left with the task of telling her. This resulted in a standoff between the doctor and CervicalCheck which meant that the 2011 error was not communicated to her -- and she did not find out about it until the following year (2017) when she spotted it in her file.
One can understand why Phelan's doctor felt this way. He clearly was unhappy with CervicalCheck passing the problem on to him. And in addition he understood that not telling Phelan in 2014 about the error in her 2011 scan had not delayed the start of her treatment in 2014 and would do nothing to improve her situation.
So the truth about the so-called cervical cancer scandal in Ireland is that it was not a cover-up which has caused women to die. The truth is that smear testing is not perfect and there will always be a small number of women in whom pre-cancerous cell abnormality is missed and who may go on to develop cancer. And in these cases that may not be spotted until a subsequent smear test.
The media here over the past two weeks have been demanding answers, calling for resignations and heaping scorn on what they call the abject failure of the HSE and cancer screening in Ireland. This near hysteria has been increased by scaremongering politicians who have shamefully used the controversy -- and the plight of the terminally ill Phelan -- to pile pressure on the government.
Underlying much of this is the suggestion that Phelan and other women may die because of "gross incompetence" in the HSE. Again, that is not true.
Much has been made of the decision to outsource smear test analysis to two laboratories in the U.S. But the fact is that the performance record of the companies involved is in line with international accuracy levels.
What is not mentioned is that when CervicalCheck, one of several successful cancer screening programs in Ireland which are saving thousands of lives every year, was set up in 2008, it was 30 years behind the setting up of cervical smear testing programs in other countries in Europe. To get it up and running and expanded nationally as quickly possible meant outsourcing some of the smear test analysis since the capacity to do this work here on the scale required did not exist.
Clearly in all this sad business there was a failure by CervicalCheck and the HSE, but it was a communications failure, not a failure to provide treatment as soon as possible for the women involved.
In the witch-hunt to find someone to blame, much damage is being done not only to the CervicalCheck program but also to confidence in other cancer screening programs run by the HSE like BowelScreen and BreastCheck. As someone whose life was saved three years ago by the BowelScreen program which identified my cancer at an early stage, I can vouch for how important these programs are.
Of course there is widespread sympathy for Phelan and anger that she was not told about the mistake. But those who are excoriating the HSE and undermining confidence in cancer screening services here should think carefully about the consequences of what they are doing.
The HSE admitted over the past two weeks that 162 of the 209 women whose smears were misread in 2011, like Phelan, had not been told of the mistake. Seventeen are now dead and the rest -- who of course have been in treatment since 2014 are being contacted as quickly as possible so that they can be told. Many of them, like Phelan who settled her case for €2.5 million, are likely to take legal action. But there are no winners in this sad business.