Oireachtas Joint and Select Committees
Wednesday, 16 May 2018
Public Accounts Committee
Management of Legal Costs and Policy on Open Disclosure (Resumed)
Implications of CervicalCheck Revelations (Resumed)
2016 Financial Statements of the State Claims Agency (Resumed)
2016 Financial Statements of the HSE (Resumed)
This evening we are resuming our discussion on matters related to State claims, management of legal costs, policy on open disclosure and the implications of the CervicalCheck revelations. We are joined by Ms Vicky Phelan, one of the women directly affected by the crisis along with her solicitor, Mr. Cian O'Carroll. We are also joined by Mr. Stephen Teap, the husband of Irene Teap who has sadly passed away from cervical cancer. Thank you for agreeing to appear before the Committee of Public Accounts this evening.
The committee has already met officials from the Department of Health, the HSE and the State Claims Agency on the matter and we will resume that side of our discussions tomorrow. For now, we want to hear from the people directly affected by this crisis. It will be key in terms of making changes to the system used by the HSE to learn from those who have had direct experience of the system. That is why their evidence to the Committee of Public Accounts is important. We want to ensure that the women and families who have been directly impacted - they are very much representative of that group - are treated appropriately especially in respect of access to their information.
We also, of course, want the cancer screening service to continue and for the population to use it. Notwithstanding the failures that have been highlighted and which have caused such public anger, it is a valuable part of our public health system. We welcome the changes that are coming in which will make screening a more accurate exercise.
Ms Phelan and Mr. Teap are here today specifically to help the members of the committee deal with the whole question of open disclosure. That matter has been discussed by the HSE and the State Claims Agency at this committee on several previous occasions. We know there is a policy position in change. We have heard from the relevant officials from those institutions in the past and no doubt we will hear from them again. However, the job of the Committee of Public Accounts is to hear all sides of the story as to how that operates in practice. Your attendance here today will help us verify what we are hearing from the State institutions on the matter. That is why your evidence today will be beneficial in bringing about improvements that are ultimately required to be implemented - by legislation if necessary - as soon as possible.
We are in your hands, Vicky and Stephen. We are here to hear your story. We are here substantially in listening mode. We will have some questions afterwards by way of clarification if you are happy to take them. We are here to listen respectfully to you. As everyone knows, we public representatives do a lot of talking, but listening is often a far more important aspect of our job.
I will start with you, Vicky. You might tell us your story in your own words.
Ms Vicky Phelan:
Thank you, Seán. Thank you all for inviting myself and Stephen here today to tell our side of the story. It is great to be able to have this opportunity for me in particular to set out my experience and to answer any questions you may have at the end of it. Some of you have already heard my story numerous times at this stage I am sure. It has been dissected in different parts of the media. For me today, it is important that you hear my side of the story from me.
I will give my timeline and go back to where this all started for me. In February 2011, I had my son, Darragh. I had a smear test about eight weeks after I had Darragh. Up to and before I had my son I had always had smears from when I was old enough to have them, before CervicalCheck came into being in 2008. I never missed a smear. I had always had normal smears. I had never had an abnormal one. I had never had any LLETZ procedures or colposcopies so I had nothing to worry about in 2011 when I went for my smear after having my son. My pregnancy with my son went absolutely perfectly. I had no bleeding - no issues whatsoever. It was a textbook pregnancy.
When I went for my smear at the end of May 2011 with my GP, I had nothing to worry about. When she rang me four weeks later with the result of that smear and told me that it was normal and that I was not due for another smear for another three years, I was not even worried, to be honest. I was not expecting the result to be anything but normal. Then in July 2014 I was first diagnosed with cervical cancer. I actually went in earlier that year - I was not even called for the smear at that point. I went to my GP in June 2014, complaining of symptoms. For me, the symptoms were bleeding in between my periods. It was nothing major, just very light bleeding, but it happened for three months in a row from March until June. I gave it three months and I decided I would go to my GP and get it checked out, and ask for my smear a little bit early. I was not due until October that year apparently when I got the letter but I went in a little bit early just to get it checked out. I still really did not have any worries but there was something at the back of my mind. I just thought it was a little bit unusual for me. I was very lucky. I am a woman who has always had very regular periods. My sister would have always had very irregular periods and so she would not have gone with the symptoms I had.
My gynaecologist at the time when I was diagnosed told me that the type of symptoms I was complaining about were very minor. I think that is something that women need to know. It does not have to be really bad back pain and haemorrhaging that will send you into your doctor for cervical cancer. I had very mild symptoms and I still got diagnosed, but now I know that my diagnosis goes back prior to 2014. What made me go to the doctor in the end was that I had a bleed after sex, basically. That is what made me really think this a little bit more serious than I thought.
When I went for my smear in June, I bled after the nurse took the smear and she said that was a bit unusual because it was quite a lot so she marked it urgent and sent it off to the lab. That particular smear in 2014 went to MedLab in Sandyford. The result came back four weeks later. I got a call when I was in work on 2 July from the GP who told me that the result had come in and she wanted to talk to me. I asked her, "Can you not talk to me over the phone? Is it just high-grade changes that involve LLETZ procedure or colposcopy?" I kind of pushed her, but she would not say anything really over the phone; she asked me to come in.
I went in when I got back after work that week. She told me that there were very high-grade changes and that she was sending me for an urgent colposcopy so I went for that urgent colposcopy two weeks later on 15 July 2014. When I had the colposcopy, I went to the colposcopy clinic in Limerick. Dr. Kevin Hickey is the lead colposcopist there in Limerick. He checked me and while he was doing the LLETZ procedure - he told me two days later when I got the result that it was cancer - but that day he did not tell me. Obviously, he had to get the result of the biopsy, but he told me he knew. He could see the tumour. I had a 4 cm tumour.
He did the LLETZ procedure and took away 3 cm of a tumour that day. It was a very uncomfortable procedure. It was not a nice experience for any woman to go through, to be honest, but I did have an inkling that something was wrong before I left his clinic because he asked me if I was finished having children. At that stage I was 39 and had two kids. Luckily enough for me I did not want any more children; I was happy with my two. I said to him, "Why? Are you telling me I have cancer?" He said, "No, no, no - I am sending your sample off for a biopsy. It's just that these changes are very high grade and we would recommend a hysterectomy." He had already booked me in for a hysterectomy at that stage. I was due to come back on 1 August for a hysterectomy.
At that stage alarm bells were ringing and I thought, "Jesus, is it cancer or is it not?" I was waiting for this call. That was 15 July. Two days later he rang me. He had the results of this biopsy and it was cancer. He said, "We're going to go ahead with the hysterectomy on 1 August, but in the meantime I'm going to send you for an MRI scan just to be sure there hasn't been any spread outside your cervix." If the cancer is contained within the cervix, a hysterectomy would sort everything out and there would be no need for chemotherapy or radiation. I went off for my MRI scan a week later on 22 July.
On 29 July, I went to Kevin Hickey for the result and my husband came with me to that appointment. Dr. Hickey told me that unfortunately the cancer was showing up as having spread outside my cervix. It was highlighted in two lymph nodes. He said that at that stage, the hysterectomy was off the table because once it spreads outside the cervix, the cancer is graded much higher. He was then going to send me for a PET scan to see if it had spread any further and whether they might see small metastases. I went for my PET scan and that came back. Luckily enough, at that stage, it was only in two lymph nodes. However, the treatment plan had changed from a hysterectomy, for which I had planned at that stage, to radical chemotherapy and radiation. I was then passed to the oncology team and put under a radiation oncologist. For people who do not have cancer, it is hard to understand. You have all these oncologists and some people are under radiation oncologists while others are under medical oncologists, depending on the primary treatment. In my case, I was having radiotherapy five days a week and my primary oncologist was a radiation oncologist, namely, Dr. Lorraine Walsh. If you are attending primarily for chemotherapy, you have a medical oncologist. Dr. Lorraine Walsh was my lead oncologist and Dr. Kevin Hickey was the gynaecologist.
I started my treatment at the start of September 2014 and it was five weeks of hell. That is the only way to describe it. I was told that type of treatment is not prescribed for everyone. I am sure Stephen will attest to that as Irene Teap had the same type of treatment. It is usually prescribed for younger women who can tolerate it. It is five days a week of radiation and one full day of chemotherapy. It is all day from 8.30 a.m. until 6.30 p.m. and you are literally green coming out of it. At the time, I was coming home to two small children. My son was only three and my daughter was eight. It was very difficult and I was in bed for two or three days, unable to move and vomiting. It is a horrible experience and one I would not wish on my worst enemy. It was very difficult. On top of the treatment, you have to put up with all of the side effects. You are very sick and are given tablets to deal with that. You cannot sleep because you are on steroids to deal with the chemotherapy. It is a vicious circle. Luckily, I did not lose my hair. I like my hair and that was one good thing. People can call it vanity if they want but it was important to me because my son loved my hair.
It was a horrendous experience. The worst part of it, which no one really explains, was to come. I am sure Stephen will say the same. It was the brachytherapy, which is internal radiation treatment. After the five weeks of hell, you get a two-week break and they then bring you in for internal radiation treatment called brachytherapy. They literally insert an applicator up inside you. They knock you out for this. It was three times in a week and a half. There were three epidurals in a week and a half. They then irradiate whatever is left up there. Whatever is left inside you is literally melted together. I have no ovaries, womb or anything at this stage. It is all melted together. That is supposed to cure you. Those two weeks were the worst part of it. I had my last treatment on my 40th birthday so that was really lovely. At the end of it, I had an MRI scan. They leave you alone for a few months to recover and it takes that long. I had an MRI scan in February 2015, which showed there was no evidence of disease. I was relieved. I cannot say I was delighted because I was still sick and in recovery from the effects of the treatment. I had no evidence of disease and they told me that was great.
The next step was to bring me in every three months for two years because I was very high risk. I was stage 1B2 in terms of my original diagnosis in 2014, but because it had spread outside the cervix into lymph nodes, I was staged much higher in treatment terms. One is staged like a stage 3 cancer because once it spreads to the lymphatic system, there is no telling where it is going to go. They have to keep a very close eye. I was being seen every three months after I finished my treatment. One goes between the gynaecologist and the oncologist every three months. I had complained consistently of back pain after I finished my treatment, however. Looking back at my medical notes, which we got when I went through my court case, I was glad to see that I was not making this up. I complained consistently at the appointments of back pain but nobody really took much notice. They just kept saying it was a normal post-radiation effect. One trusts the doctors and assumes they know what they are doing and, as such, I believed them. I got to my two-year timeline and I thought that was good. They say that if you get past the first two years, you are doing really well. The next step after that is five years when you are really flying it. Obviously, I have not got to the five years and am back now with terminal cancer. I barely got to the four years, to be honest.
When I went back to Kevin Hickey for my check-up in September 2017, I was not feeling any worse than usual. I was fine and had no reduction in my energy levels. However, I had this lower back pain. The previous year, 2016, I booked myself into Barringtons Hospital privately for an ultrasound because I had this tugging sensation in my abdomen. I thought I had pulled a muscle or something as I was weight-lifting at that stage and trying to get back into exercise. However, it did not clear up so I went for the ultrasound. It could not explain the tugging and came back as normal. As such, I did not think anything of it. When I went to Kevin Hickey in September, I told him about the usual back pain and this tugging sensation in my abdomen. I had a pelvic exam, an internal exam, and he did not find anything wrong at that stage. Everything looked normal as far as he was concerned. He told me he would send me for a scan just to be sure. At that stage in September, when I had this meeting, I still did not have cancer. That is important to bear in mind with what I was told then.
I went for a scan in November and that was when I found out cancer was back. Once I went through the whole round of MRIs and PET scans, I found out, just after Christmas, that my cancer was back and was literally up my body. It is in my paraaortic lymph nodes so it is in a chain all around my aorta. It is touching off all my organs. Approximately five lymph nodes are forming a 10 cm mass around my aorta. All of one's vital organs are around there. Part of it is touching off my kidneys, my lungs and my liver. As such, I am not a candidate for surgery or radiation. All they would offer me was palliative chemotherapy. I went to see my radiation oncologist on 12 January this year and was told the only option open to me was palliative chemotherapy. No other treatment was available. If I took the palliative chemotherapy option, I had 12 months and, if I did not, I had six months to live. I pushed her to find out the timeframes as she was not willingly going to tell me. That is where I am at the moment with a terminal diagnosis.
I will rewind a bit to that meeting I had with Dr. Hickey in September 2017 when he sent me for the scan to find out what I know now, that I have terminal cancer. He told me then that he wanted to have a chat with me about the audit the cervical screening programme had carried out. He told me audits are carried out as a matter of routine when women are diagnosed with cervical cancer. That triggers a check. When a woman is diagnosed with cervical cancer, CervicalCheck will look at her screening history to see if there was anything which might have been missed. The smear which diagnosed my cancer was in 2014. My previous smear was in May 2011, eight weeks after the birth of my son, and I had been told it was normal. When they retested it, he told me, there was now a query about the smear. He did not actually say it was cancer at that meeting, he just said there was a query and that I may have had cancer or the starting of cancer, pre-cancer, in 2011.
When I was in with him in September, I was not in a state of mind to take this any further for two reasons. First, I was cancer-free as far as I was aware. That changed two months later. Second, as a family my husband and I had a lot of medical issues to deal with for my daughter who has a congenital disorder. Last year, in 2017, she had two full tonic-clonic epileptic seizures in school, which came out of nowhere. It is a result of her congenital toxoplasmosis diagnosis, which led to a reactivation. Basically, she has a parasite living at the back of her eye. I was diagnosed when I was pregnant and she was treated for 12 months when she was a baby. We went through the early intervention programme.
She had a stroke effect on her left-hand side. We had awful problems with her. She is basically blind in one eye. She has 70% vision in the other eye but we thought we had dealt with it. We were very lucky that she was not brain damaged and that she was not blind. We were very happy that she was doing really well in school. All of a sudden this kicked off in 2016 but it is all because of puberty. She has hit puberty, she is nearly 13. We went back down the whole rollercoaster of medication for her. She was now on anti-epileptic medication as well as medication to treat her condition. She nearly lost her eyesight during the summer of 2017. We had to take her to Moorfields Eye Hospital in the United Kingdom. She had to have laser surgery.
I had enough going on at that stage without trying to get my head around knowing that I probably had cancer in 2011 so I did not take it further in September. When I found out in November I knew at that stage that I was going to have to do something but I waited until I knew what my treatment plan was. There is all this waiting with scans, going from MRI scans, to PET scans to treatment plans. When they told me it was terminal I was trying to get my head around it but I was not going to accept a terminal prognosis and went to research other options at that stage.
By the time I went to see the medical oncologist about options for the palliative chemotherapy I had insisted on a biopsy because I wanted to be 100% sure this was the same cancer I had, not a new cancer because the treatment would be different. On 19 January I was waiting to have my biopsy. Myself and my mother were sitting in a treatment room waiting for a bed, as you do with the HSE. We were there for about four hours. I was very bored. I had my file because it had been sent up with me from admissions. I started looking through it. I still had not made the decision about whether I was going to go further legally about this missed smear. As I was going through my file I noticed this letter from CervicalCheck and when I read it I could see the smear test date, 24 May 2011. This is the report that CervicalCheck sent back to my gynaecologist on the review of my smear from 2011. The original report stated no abnormality detected, NAD. The review was query squamous cell carcinoma.
At that stage alarm bells started ringing in my head because Mr. Hickey was very vague in September and just said that there was a query, that there may have been a question about me having cancer in 2011 but this was in black and white, quite clear, this is cancer. I then noticed at the end of the page that this was page 2 of two of this report. I work in administration so I notice these things even though it is tiny, page 2 of two. I was sitting there asking my mother "Jesus, where's page 1?". Mam said "Ah sure it's probably just a cover page." I said, "Well, yeah, but from who, to who and when was it dated?" because at that stage I started questioning when this was sent. When I thought back to the conversation with Mr. Hickey I assumed that the audit had been carried out just that year, in 2017. I took a photo of that and anything else in my file and straightaway started researching medical negligence solicitors. I contacted Cian O'Carroll on 30 January, I was in his office and that was the start of me taking my court case. We requested files then from CervicalCheck and that was the start of all this coming out.
I was not affected by the delay in being told that my cancer went back to 2011 and make no mistake about it, I had cancer in 2011 - it was not pre-cancer, it was cancer. The misdiagnosis in my case, and I know this is not the case for other women in this audit, has cost me my life. I have got terminal cancer. I do not believe I am going to die but at the end of the day I am going to have to fight to live for the rest of my life and go from one treatment option to another until I find something to cure me but I should not be in this position at all, if my cancer had been picked up on that smear where there were plenty of cancer cells, there is no question from the expert cytologist on my legal team. The person looking at my smear sample either was not competent or did not look at it at all because it was full of cancer. It is not that there was a small little bit of cancer on the slide, it was full of cancer. I could have been one of the women, like Irene, Stephen's wife, who was not given the chance to find out and was not given the chance to fight. Stephen is here on her behalf. At least I am still here to tell the tale. That is why I am fighting with everything in my being not only to live but to get to the bottom of this because it is a disgrace that we have been put in this position.
There are three issues, first, open disclosure, which did not happen in my case, too little too late. Mr. Hickey told me in September 2017 about this audit. When we got the correspondence back through disclosure we found out that this audit was carried out in October 2014 on my smear. I was diagnosed in July 2014. It took a full two years to decide to communicate this to clinicians so it was July 2016 before CervicalCheck communicated my particular case to my gynaecologist. Then there was 15 months of correspondence between the head of CervicalCheck and my gynaecologist about whose responsibility it was to tell me, 15 months of them deciding "You tell her", "No you tell her" before he finally told me in September 2017.
People will say it would not have made any difference at that stage because I already had cancer but I know the type of person I am, and Stephen will tell you the same about Irene, I would want to know that. They should have told me that. That is my information. I am the patient. It is my information that was hidden from me. I would probably have asked for more scans if I had known "Jesus hang on a minute here, I don't have cancer only since 2014, in fact it's going back a further three years." We know with cervical cancer the longer you have it the worse your prognosis. That would have made me be more on top of my gynaecologist and oncologist and look for more scans and maybe it would have been picked up a little sooner and I would not be in this position.
Patient safety is another issue. Why were serious errors highlighted by these audits not treated as patient safety incidents? In the briefing note sent to the Minister with regard to my case before it went to court, Jerome Coffey gave a written opinion to say that my mistake was not a patient safety issue. I would like to know does Jerome Coffey, who is the head of the National Cancer Control Programme, NCCP, still believe this to be the case now that there are 18 women dead and 209 women involved. If it is his view is he the appropriate person to be in charge?
The other question I have is who are the senior management team who approved this communication strategy which has come out? We have seen various iterations of it in the press over the past few days. Who approved this communications strategy and who decided it was okay not only not to tell the clinicians but not to tell the patients? Why was the HSE more worried about being sued by the labs, such as Quest, than communicating the information on incorrect or misread smears to patients? That fills the gap for us, to know that in the two years between my audit and the communication I received from my gynaecologist there was a full 12 months of wrangling between the HSE and one of these labs about disclosing information to clinicians never mind patients. Where is the open disclosure in this instance? Who stood over these contracts?
My questions are about open disclosure, patient safety and the labs. With regard to the labs, who stood over these contracts where patient safety and open disclosure were not considered to be important issues? When you think of the legal wrangling they were having with these labs where the labs were basically saying their contracts stipulated that the clinicians were not to be told because these were for educational purposes. The reason my case went to court and I had to give evidence, and it went on for four days, was that the lab was insisting on a confidentiality clause because this was agreed as part of its contract with the HSE. They are the two big issues I see with the labs. I want to know who stood over these contracts, if they were reading them. Patient safety and open disclosure were clearly not included if you read through their stipulations. How can anyone stand over that and give these people contracts?
I think that is it.
If there anything else I need to say, the big thing for me is patient safety. I am not interested in revenge. That is not what I am here for. I want to see accountability and I would like to see a legacy that this will never happen again to any woman, man or child in this country. This is not just an issue for women. This is affecting men and children who are without their wives and their mothers. I never want to see this happen again. If I do die, I do not want it to be in vain. I want to make sure that protocols put in place, that there are sanctions for people who make these mistakes and that they are held accountable. The HSE should be overhauled, and I mean overhauled from the ground up, so that people are held accountable and that this will never happen again in any shape or form.
Mr. Stephen Teap:
No worries. Thanks very much for the opportunity to speak to you all today. I am here representing my late wife, Irene, who died in July last year at the age of 35. I am going to begin just over two weeks ago when the HSE first contacted me. It was Tuesday, 1 May, around 2.30 p.m. I was in work and got a call from a non-clinical adviser from the HSE. I was advised that Irene was one of the 17 women at the time whose name had come up in the most recent audit. We now know that is 18.
I requested there and then - there is obviously no good time to receive a call like that - a face-to-face meeting. I said I could not have that conversation over the phone. I did ask what smear tests were being referred to in respect of this audit and I was told 2013 and 2010. I asked whether they going back as far as 2010. The woman on the phone pointed out that she was not a clinical adviser and that I needed to come in and meet a consultant next Thursday night at 7.30 p.m.
I asked on Thursday night why a non-clinical adviser was phoning to tell us this. Why was it done over the phone? Why could someone not have called out to my house? I was told then that a decision had been made that no medical staff were going to make the phone calls because they did not want us asking any questions over the telephone when we received those calls on Tuesday, 1 May.
On Thursday, 3 May, at 7.30 p.m. we arrived in St. Finbarr's Hospital in Cork. I was there with Irene's mum and dad. We were brought into a waiting room within the hospital. It was just a standard hospital waiting room. We were passing women on the way out the doors of St. Finbarr's who were upset. We were brought into an empty waiting room with vending machines in the corners and a television on and just told to wait there. A girl walked in with her mum and dad. I would say if she was 30 that would be a lot. They sat down behind us. I was trying to get my head around the fact of whether we were actually being brought in with all of the other victims of this audit. Surely not, that would have been a bit insensitive. I turned around to that family and asked were they one of the 205 or 206, as it was at the time. The mother turned to me and said "yes, we are. And you?". I said that we were one of the 17. The daughter of that family just got up then and left the waiting room. She was clearly upset by that.
We waited there alongside that family for the next half hour. Then we were brought in to see the consultant. He was actually the consultant that Irene was referred to on day one. There was just him, a nurse and Irene's mum and dad. We sat down. Irene's file was open on the table with the CervicalCheck audit on it. The last time I saw that file was 14 July last year, when we were given Irene's terminal diagnosis in hospital. It was the same bulky file with all of her information in it. The consultant started reading through the audit with us. It was like the piece of paper that was shared a minute ago. He shared with us that were two sides to the page. On the left-hand side were the smear tests which Irene had done and the results that her GP would have been given. On the right-hand side of the page were the results from the audit carried out on these two smear tests.
Obviously, Irene was led to believe that both of these smear tests came back clean. The 2010 test said to call back in three years and the 2013 test said to call back in three to five years' time. When these were audited, it turned out that the 2010 test had pre-cancerous cells in it. That was the result from the audit. I asked what this would have triggered if Irene had got these results on day one. I was told they would have brought her back in, they would have done a physical examination and would have performed a procedure where they would have burned away the cells. The chances are that would have been it then. She would have been told to go and live the rest of her life. As the consultant pointed out to us, 2013 was the most concerning of the two smear tests because this had the beginnings of cancer. This was the biggest concern because Irene would have been called in straight away. She would have gone through treatment. Again, she could have gone on to live a happy life with us - with me and my two boys.
The question is how did Irene find out she had cancer. It was not from a screening process. Irene had two missed opportunities for cancer to be identified in her smear tests. If it had been identified in either one, she would still be here with us today. I have heard through different sources and through the media that these smear tests are accurate up to 70% or up to 90%. They might have 10% inaccuracy. In Irene's case it was 100% inaccurate. Two consecutive smear tests were missed and two opportunities to save her life.
On 21 April 2015, Irene gave birth to our youngest boy, Noah. Soon after that, Irene noticed she was not recovering from childbirth. She was still bleeding. About five or six weeks after Noah was born, she went back into Cork University Maternity Hospital, CUMH, for an examination. She was given some statistic. I am not sure what it was but it was on the lines of so many women can bleed up to eight weeks and ten weeks after birth. It was a rarity but did happen. At eight weeks, Irene was still bleeding. She went back to the GP and got an appointment to go back in to see a consultant in CUMH and at 12 weeks she went back in.
At that stage, her cervix was looked at. There was nothing wrong with it. It was going along the lines of maybe Irene had some kind of hormone imbalance and that was why she was not recovering from childbirth. They were going to write her a prescription to balance her hormones. Essentially that prescription would have been for the contraceptive pill. Irene was breastfeeding Noah. He was 12 weeks old. Irene knew that this medicine that she had been prescribed would dry up her milk supply and she would be unable to feed Noah. She refused it straight away.
At 18 weeks, Irene was still bleeding and she went back to her GP. Her GP referred her back to the CUMH to see the same consultant again. They decided then to do a dilation and curettage, D and C, procedure because they were thinking that maybe some elements of childbirth still left in her womb might be causing an infection. They said that if they carried out a D and C that might get rid of the bleeding. When they were doing the D and C on Irene, the consultant that had seen her at 12 weeks noticed there was a change in her cervix at that point, at 20 weeks.
They took a sample and tested it. It was then that Irene was diagnosed with cervical cancer. At this point, we had a five-month-old boy being breast-fed and a two-and-a-half-year-old boy and Irene needed to start that gruelling treatment that Vicky went into detail about - radiotherapy, chemotherapy and brachytherapy at the end - for eight weeks. As Vicky mentioned, this is a horrible experience - all of it. The eight weeks of treatment are gruelling. The medication and steroids - everything you are put on just makes you sick. It was a very difficult time for all of us but we are fighters. Irene led the pack and we just got on with it. When you have two small children, you have to fight this. At the end of the eight weeks, you have the horrible wait of three months for that scan to review how this treatment has gone. That brought us up to around February when we had that scan. In March, we were told the treatment went very well. When Irene had been diagnosed that previous September, she had been diagnosed with stage 2 cancer and they told us they would be treating for cure. So when they told us in March that all that was left was scar tissue from the tumour on her cervix, obviously we were delighted with that. Everything seemed to be working fine.
During the summer, Irene started to get progressively sick again with back pain and pain down her legs. It go so bad that she was getting up in the middle of the night to take pain medication and to make up water bottles. When we went back for our appointment in September 2016, after a couple of weeks of testing, Irene was told that she had secondary liver cancer and tumours in her lungs. They did not discuss treating for cure at this point. They never said it was terminal. They just said we would now be living with cancer, that they had a very aggressive chemotherapy treatment plan, that after that, they had plan B and that after that, they had plan C. Irene went through this chemotherapy involving one day of chemotherapy and going back every three weeks. You are floored in the first week of this chemotherapy. In the second week, you are coming back together and in the third week, you are up and running again. Then you get slammed again with another dose of this chemotherapy and you are wiped out again. It is just a continuous cycle for 12 weeks. After a second dose of chemotherapy, Irene lost all her hair. She said "I am now a sick person" because, as Vicky said, you do not lose your hair the first time and can still blend into the crowd and nobody knows what is going on but this time, as she said, people were giving up their seats for her and opening doors. You are now sick. This treatment lasted until January. We had a scan that said the tumour on her liver was shrinking. Less than a month later, we had another scan saying it was growing again. Irene spent every second or third week in hospital in early 2017 - infection after infection after infection - up to the point of 14 July 2017 when they sat us down and said there was no more they could do for us and were stopping all treatment. When we asked how long we had, they said a few short weeks and that they hoped we would get to the end of the summer. Irene's only ambition there and then was to see our eldest guy start primary school at the end of August. Irene only lasted a week and a half later. She passed away on 26 July.
The HSE received the audit results on 3 July last year - just over three weeks before Irene died. It decided there and then that it was not going to share that information with Irene or me. At that meeting on the evening of Thursday, 3 May, I was told a team of counsel made the conscious decision not to share the information with Irene or me. They thought she was a bit too sick. This was 3 July. She did not get her terminal diagnosis until 14 July. They did not know if she was going to live for three weeks. They did not have a clue at that point. We told him that this was not his decision to make - how dare he? If he knew Irene at all, he would know that if she had three minutes to live and this information landed across her desk, she would want to know exactly what that was about. The next morning, 12 hours later, I got another call from this consultant. He said to me that he gave me misleading information at our meeting the previous night. He did not do it deliberately but he wanted to correct it. He said that the counsel - the team of people he met - did not actually tell him not to pass on the information to Irene or me and that they actually said that it was about open disclosure and told him to contact CervicalCheck. Somewhere within the 12 hours, this consultant was clearly reminded of the company line and made a conscious effort to get in touch with me quickly just to correct exactly what he said. When I asked him what happened when he did contact CervicalCheck, he said he did not know, which was odd because you would think that would be the first question I was going to ask. He did not have that information for me. I politely reminded him that this was a big part of the puzzle and that I wanted to know exactly what conversation he had. I said that he was told about open disclosure and then told to contact CervicalCheck so I asked the conversation was. I told him he needed to find this out to which I got the smart response that he would have a look and that he needed to trawl back through 2,000 or 3,000 emails but that he would have a look. I told him that he had better do that and that I wanted to know that. He replied that it may have been a verbal communication and that he did not know 100%. I think we can all take it that I will probably never find out the answer to that question. That is a problem.
This lack of open disclosure within the HSE is clearly a problem. The communication between senior management and consultants is an issue. Communication between senior management and the Department of Health is an issue. From what we have learned in the past 24 hours, communication between the Department of Health and the Government is clearly an issue. While it exists with a fantastic nursing staff and the majority of consultants - I have to give credit to the nursing staff who took really good care of my wife - clearly patient care is diluted up the ladder and the element of protect and deny is introduced. That is basically what we have seen in the past few weeks when it comes to all of this communication or the lack of communication we are being fed, the lack of communication with Irene, the lack of communication with me and the lack of communication with her GP. I had to inform Irene's GP that she was one of the 17 women who were audited. I had to inform Irene's GP about the results of the audit. Irene's GP is not only her GP but the GP of her three sisters, her mother and father, my two boys and my niece and nephew. He is the family doctor and he was never consulted about any part of this. I have copies of the smear tests he performed in his clinic and they could not even give him the audited results of the tests he conducted. Information was clearly withheld from him and it looks like information was clearly withheld from the Ministers. We have to take them at their word that they did not receive this information.
It seems that the people in these senior positions who knew about all of these memos in 2016 are the same people in senior positions today who need to be questioned when it comes to these inquiries. I do not understand how they can sit in these positions while inquiries are ongoing. We have dead women here. We have women who have been given terminal diagnoses - death sentences. We are talking about 209 women, of whom 18 are dead. We still do not know how many of the rest have a terminal diagnosis, how many are still going through treatment and how many have finished treatment and are lucky enough to be out the other side. It is how many weeks later and they still cannot give us this information.
We have two people gone but more need to go now. They need to step aside. They have to get out of the way so these inquiries can take place. Right now, they know where all the answers to the questions lie. They know the places not to look or to keep us away from and they are clearly sitting on this information, preventing us from getting it. It is obvious that this is going on from the drip-drip feed that Oireachtas Members seem to be getting at these committee meetings. I welcome the Scally inquiry. It is important that we have a third party inquiry on this. He needs to speak to the same people that are sitting in these senior positions who are deliberately covering up information. If someone knows something about another department and mistakes are being made, and that information is not being passed on, that is a cover-up. If other people are involved in not sharing that information, they are now part of that cover-up too, yet they all remain in senior positions in the HSE. That is a huge concern of mine.
Last Thursday, when I left the meeting, I left with nothing. Nothing was offered. There were no support services, nothing for me to help my kids through their bereavement. Oscar was four when his mum died and Noah was two. They are five and three today. Ten to 15 years from now, they will be reading all about this in the papers and they will look at what their dad was doing here today. What is there to help me prepare them for that? What is there when they see two missed opportunities to save their mother's life? How do I communicate that with them?
I am one of now 17 families. There are close to 200 women. We do not know how many are terminal and how many are going through cancer treatment. When one is going through that horrible process of treatment for cancer, one's mental attitude towards that treatment is very important. How do you think these women feel in the last couple of weeks after having these meetings and being told that a few smear tests were missed that could have saved their lives? Maybe they would not have to go through cancer treatment, maybe they are not terminal and maybe they do not have to die.
On top of that, they have to fight for their life while having to process that information. When the HSE informed them of this audit, it just sent them back out the door with no support services. There was absolutely nothing but a "Goodbye, there you go". This is why, from the beginning, I decided to share Irene's story because that is exactly what she would have wanted. If she got this information three weeks or three minutes before she died, we would all know about that story. She would have been shouting the same thing that I am shouting. The support services took almost a week to be put in place from the second I started roaring and shouting about it. We heard the announcement last Friday of all these support services, which I welcome. They are great. The problem is that I still have not heard anything. I know you have not heard anything. I do not think anybody has heard anything. Will this come in for us in 2020 or 2021? Those support services should have been in place two or three weeks ago when we were sitting with the HSE, and they were not. It is another example of the lack of patient care within the HSE.
The HSE needs to be reformed, particularly at the senior level. It needs to start looking at how it is run from the ground up and the staff that are there today, looking after patients. Patient care needs to be put in the backbone of the HSE, right up to senior management. Communication is key.
Mr. Stephen Teap:
I am not interested in open disclosure but am more interested in mandatory disclosure. Mandatory disclosure is worthless unless sanctions are put in place to coincide with that. That is sanctions on the individual. One cannot tell someone to do something and then have nothing happen if they do not. It will not work. There need to be serious sanctions in place for this. With regard to any reform in the HSE, legislation needs to be put in place to coincide with it to make it work. I agree with all of Vicky's points about what needs to be done.
I thank Stephen and Vicky sincerely for telling us your story here today. We are grateful to listen to the harrowing stories. It is a deeply humbling experience for me and for most of us. We are here to listen and we have listened to the failures of the State and State institutions that resulted in the needless deaths of women. You are here, helping the Oireachtas and Government make sure that is right for the future. Everything will have been in vain if there are no fundamental changes for the future. Some good may come out of the harrowing stories if real improvements are made and situations like this never occur again. Are you open for comment or a question or two from members of the committee?
I propose that I take comments and a question or two. I will take three people together. We cannot have one question with ten sets of people putting questions. I know everybody will be conscious of the difficult situation that we are in. Speakers have indicated in the following sequence and, to the best of my ability, this is the list I have taken: Deputies David Cullinane, Marc MacSharry, Catherine Murphy, Alan Kelly, Kate O'Connell, Jonathan O'Brien and Shane Cassells. I will take three at a time to make it easy. They may have comments to make or some questions to put. I will take the three people together and then we will go back to Vicky and Stephen to respond if they see fit. I ask Deputies David Cullinane, Marc MacSharry and Catherine Murphy to make some observations.
I do not know what to say to Vicky, Stephen and others. Thank you for coming here and sharing your stories with us. As you know, we had representatives of the HSE and Department before us last week. We will have more representatives before us tomorrow. Some of those people that Stephen spoke about that knew about the strategy, the memo and the cover-up which has been referred to, will be here tomorrow. We will ask the hard questions on your behalf, on Vicky's behalf and all of the women's behalf, and of those husbands and partners who are suffering.
Any of you can answer this question but I know that Vicky's solicitor has very publicly said that he believes that there is a cover-up in the main centres relating to the lack of open disclosure, the fact that discretion was given to consultants and, in the cases of women who passed away, the information was not passed on to their next of kin. We heard Stephen's story. If Mr. Cian O'Carroll is in a position to address the committee, he might expand on that a bit more with regard to his view of a cover-up and what exactly he meant by that. He might also, if he can - and Vicky or Stephen can respond to this too - talk to me about how people were selected for audit in the first place. Given the documentation that emerged yesterday, does Mr. O'Carroll feel there were any discrepancies or issues relating to how people were selected for the audit?
I am looking at a questions and answers document that was prepared for the Department and the HSE. It talks about the 1,120 cases that were part of the audit by December 2015. It says that 317 cases, which is 28.3% of the total cases, were flagged for further review. In most, though not all, of these reviewed cases, there may have been an opportunity for earlier intervention. This includes pre-cancerous cell changes that were not detected. Those for whom this resulted in a delay in diagnosis of treatment are most likely dead.
I want to ask Stephen if that is what happened to Irene and whether she is in that category. Vicky, how is that different from your own experience? You said yours potentially might have been an outlier, or was it that it was an outlier in terms of how your smear test was so badly misread?
In terms of Mr. O'Carroll's work, did he discover any problems with the lab itself? Vicky put it extremely well, better than anybody could, that the issues are open disclosure and patient safety. I find it incredible that the HSE and the Department are still saying there are no patient safety issues when we clearly heard what happened in your case. It is beyond words that they still say that, but you also talked about the labs. When you talked about the labs being an issue, are you talking about the performance of the labs, issues in relation to the labs and the relationship between the labs possibly preventing information getting to patients because of contractual issues? Is that the issue? You might be able to come back on some of those points.
Those are the questions I have. I will finish by saying that I think everybody admires your bravery and your courage, Vicky, as well as yours, Stephen. I genuinely wish you both well. It is sad you have had to come here and tell your story but I think it is worthwhile for us in view of our preparations for tomorrow.
I have been in the Oireachtas since 2002. I am ashamed that, as the body that is supposed to hold all of these organisations to account, we have all spectacularly failed you, and for that I am personally sorry. I have two questions, one for each, although you covered it, Stephen. Normally, we call people "Mister" and so on in here but if you do not mind, we can be more informal. Given the work that is under way, and you did touch on this, you may want to add something in terms of the Scally scoping report. We also have the indication of a commission of investigation after that and the indication of a peer review, as well as the work of the health committee and this committee. In terms of accountability, if there are any tangible actions both of you would like to see now, you might expand on that. Clearly, you have highlighted an awful lot that, as Deputy Cullinane said, will feed into our questioning tomorrow, and we will do that.
The other comment is that the principles of care that underpin actions in Ireland are from the Royal College of Obstetricians and Gynaecologists following the report in 2011. The first of them is that the woman must be at the centre of her own care. Have you any comment on that, give it is supposed to be principle No. 1?
Very finally and quite specifically, and Deputy Cullinane touched on this, you mentioned that MedLab was the lab where your test was. We know from its confirmation and a statement on Sunday that it subcontracted to a third-party laboratory, and we will be asking on contractual issues about that tomorrow. I know from speaking to some GPs that all the results coming back to them were signed by an Irish-registered pathologist. I wondered if there was any information you had as to whether your tests were done on-site there, or were they a part of the backlog situation where MedLab subcontracted this work. If it was a subcontracted test, were you or your physicians informed of that in your own research through the legal process or otherwise? If so, is it the case that the Irish-registered pathologist based in Sandyford is transcribing results from another lab and just signing off on them, taking them as correct, or is that person looking under a microscope to say, "Yes, I concur with that", and then signing off on them? That is something that would be useful for us to know in terms of the process.
Again, I want to thank you very much for being here today and for all you have done.
Thank you very much for coming in and sharing your stories with us. We have had the HSE in at this committee routinely on various issues. Very often, it is about something much more academic and we are trying to understand something and humanise it. Unfortunately, we tend to get change in this country by people putting themselves forward, putting themselves out there in a way that really should not have to happen. Whether it is the Garda, the health service or otherwise, that seems to be what is important in terms of triggering public understanding of the failure of our system. That is why it is so important that you have both gone so public in a situation that is so personal to yourselves.
I have a couple of questions. I know there are a lot of us here and I do not want to delay you. One thing jumped out at me, Vicky, in regard to one of the points you made, and that was about the contractual obligation between the HSE and the lab. Did the contract actually have a requirement for confidentiality? Were there other things, as in the court, that jumped out to you, and that may well be more nuanced, but that would be helpful for us in exploring how we make changes to the system? Stephen, I have to say the way you have been told, and the way this has been handled, has compounded the problem or - I should not call it a problem - has compounded the crisis. The situation where you were brought in and told in such an insensitive way, plus the fact the supports are not there for you, is something of which we have to take very serious note because that is as much to do with the care as everything else that has transpired before this. Thank you for sharing that because it is that understanding of putting the patient at the centre that is central to what we should be doing.
Thank you. Vicky and Stephen, you might respond in any way you can. You might not know the answer on some of the issues, given they have to do with the HSE and so on, but any observations you have would be appreciated. Cian, you can come in at any stage you want to.
Mr. Cian O'Carroll:
Deputy Cullinane raised the issue of the cover-up as a first point. It is an emotive term but I think it is fair to say that, from the documentation, you can clearly see there was a co-ordinated and a premeditated plan to deny patients the information, although not in total. The documentation suggests that it was envisaged that some patients would be told of the audit, albeit quite late in the day. Nobody was to be told before the middle of 2016 and, at that point, people were to be selected. It is the criteria for their selection that causes a major problem for disclosure. We see from the documentation that doctors were told not only could they be selective with their patients, but if the woman had died, they were not to tell her family and it was simply to be put in the file. That appears in a number of documents and it turns up in the CervicalCheck preprinted leaflet that was sent out to the clinicians telling them how to deal with the audit in July 2016. More than 120 pages of documents were released yesterday by the Department of Health.
I have not considered them in detail, but I did notice that there is a set of precedent letters towards the back of that bundle which are to be used by CervicalCheck. Included in that bundle is a letter to clinicians. The letter includes a line about open disclosure but beside that, in the Microsoft Word format, is a comment which tells the person reading the precedent document that in cases where a woman has died this sentence is to be deleted from the letter and there is to be no reference to open disclosure. Therefore, we see that there is a thread moving through documents which suggests that there was a premeditated and orchestrated plan to keep this information from patients who had died in particular.
Furthermore, in the correspondence between CervicalCheck's Professor Flannelly and Vicky's consultant gynaecologist, there is a dialogue going on over a period of more than a year - 15 months - in which two clinicians are talking to one another and in which CervicalCheck's clinical director is saying that she does not believe that all these women should be told. At one point she describes three of the ten patients who were on that list as meeting her clinical criteria for being told, yet we know that all of those women had suffered some degree of delay in the treatment of their cancer. While I cannot comment in any meaningful way about the degree to which they were all affected by that delay, from the reports of this audit I have seen to date - and the records have been slow in coming through - four out of four women have been significantly affected. It is reasonable at least to say that doctors looking at those records must have known that there had been a very significant clinical effect on women.
Mr. Stephen Teap:
There were two questions asked. Did we know where the smear tests were screened? Halfway down the page of Irene's 2010 result it said that the test had been processed in Austin, Texas. There was no reference to where the test had been processed in the 2013 result. While it is on the same headed paper, there is no information on the most recent result. Was Irene's case flagged for further review? The answer is that I do not know. All we were told was the outcome of the audit. I did ask what the process for the audit was. I asked the consultant that. He did not know the answer but, thankfully, there was a nurse in the room who did. She could only speak on behalf of the clinic in St. Finbarr's. She explained the process there to me. Irene did not attend that clinic but it is where the tests for cervical cancer are done. She said that once a month a list is compiled of the names of all the women who have been diagnosed with cervical cancer and it is sent off to the register. It is there that the audit process begins. I asked how long it takes for an audit to take place. The nurse in question said that she had the exact same question earlier that week and had made a phone call to CervicalCheck which said that it would be six or seven months before an audit would be returned. Irene's audit took 22 months and I believe Vicky's took nearly----
Ms Vicky Phelan:
David was asking about the laboratories, the performance, the relationship between laboratories and whether they were preventing information getting to patients. With the memos last week we discovered that this was clearly the case with one of the laboratories in particular. That answered a question for us because we were wondering why there had been this delay of two years. My audit was triggered in October 2014 and then in July 2016, almost two years later, CervicalCheck contacted my gynaecologist to inform him that I was one of these cases and that he was to use his judgment on whether to inform me. It took another 15 months, until September 2017, before he actually did tell me. We were wondering what the delay had been. Gráinne Flannelly was interviewed on "Morning Ireland" and that interview answered one of the questions because she said it took them a while to come up with this communications strategy. That strategy had to be decided on and we were asking "Jesus, could that take two years?" That was one explanation. Then when these memos came out last week they showed that the laboratory was thinking about suing the HSE because it did not want the clinicians to know, let alone the patients. How long did that legal wrangling between the HSE and the laboratory go on for? My question is where was the patient in all of this? Nobody really cared about whether the patient should be told. It was about the legal wrangling between the HSE and the laboratory.
Mr. Cian O'Carroll:
In the committee's considerations and in its questioning of other witnesses one thing that occurred to us was that there has been an awful lot of talk about the statistical issues in screenings, the problems and the occurrences of false negatives. Perhaps the committee members could be mindful in their questioning that this can be used as a major distraction. I cannot speak about Irene's medical records but what happened to Vicky Phelan, and what I have seen in other situations, is that an error occurred in the reading of the original smear which was of an unacceptable magnitude. While technically it may be correct to call that a false negative, if one simply rests on it as a false negative and a statistical occurrence one closes one's mind to the necessary investigation of the cause of that failure.
It would be beneficial for patient safety if there was some questioning of the relevant key witnesses as to why clinical directors and other clinical people involved in CervicalCheck and the Department of Health appeared to have closed their minds to the magnitude of the errors which were coming back to them through the audit. They were largely doctors and it must have been quite evident to them, from these 209 cases which involved a significant delay in the commencement of treatment, that there might have been someone in those laboratories who was simply incompetent or that there might have been other factors causing this. The fact that only a month ago a memo from the senior medical people involved in cancer screening in Ireland to the Minister for Health stated that an error of that magnitude in Vicky Phelan's case was not a patient safety incident confirms that they have never investigated the error in her case. In the absence of investigation, clearly there is no intention to learn.
I am lost for words to be honest. The strength that both of the witnesses have shown is frankly incredible. Vicky does not live that far away from me even though we live in different counties. We will be shouting against one another on Sunday when Limerick plays Tipperary. With regard to the way in which Stephen has told his story in such a short space of time, because he has not known his information for that long, and the strength that he has shown in being able to tell us all so quickly, the mix between his comments and Vicky's is very important.
It is a dynamic in itself.
I very much take on board what Cian said in respect of those questions because he is right. I am a member of the Joint Committee on Health and of this committee, and these guys have been in front of us a great deal. They do not specifically accept what you are saying and they will have to be challenged. We are going to have to go down the path of, almost, looking at individual cases in order to get those answers because they are generalised.
I have a couple of comments and questions for Vicky and Stephen. They can answer in whichever way they want. I was very much taken by what Stephen said about what the consultant told him and what the consultant said when Stephen challenged him. Let me just say that, as far as I am concerned, and with regard to what we all do or try to do, he is entitled to get the answer to that question and we will not leave a stone unturned. Stephen is entitled to know what happened and he is entitled to know what was said during that phone call because it was not that long ago. It is endemic in the context of the cultural issues and other issues we have here, which come right up to this very bloody day. We have to find out. I think about open disclosure and all of the documents with which I and other colleagues were presented yesterday. I counted 35 people between the Department and the HSE-----
Open disclosure? Come on, open disclosure is a joke. I look at the letters that were drafted. Cian made reference to them earlier. There was that awful commentary to the effect that in cases where the woman died, the result should simply be recorded. I think of Irene and what was going on until Vicky blew the lid off it and then she was communicated with. Then they had to tell her. That is what was going on. We can join up the dots here. That is what was going on. Vicky created the environment whereby they had to tell her and they have not even told her everything yet. It is a scandal of the highest order in the history of the State. We can join up the dots. If we look at these documents, we can join them up. I have done out a timeline and we can join it all up.
I have a couple of questions. I am with Stephen and Vicky on this, not because of the individuals involved - I actually know some of these people and some I do not - but because I agree that this is a live issue. We are playing with people's lives. Individuals who have made decisions about people's lives are still in position. Stephen has been very articulate in saying that people who are in position should step aside while the investigation is going on and Dr. Scally is doing his work. Is that something that Vicky agrees with 100%?
Mr. Stephen Teap:
-----while an investigation was ongoing, sitting on all of that information. It needs to be followed through. If it is 35 people, so be it. They cannot remain in positions of power or senior management with such a scandal underneath them. People are dead. People have been handed death sentences.
I want to ask Vicky this question. Obviously, herself and Cian have gone through what they have. We now know the length of time that information on Vicky's situation was being bounced around by Mr. Hickey and CervicalCheck. If senior management at national level in the HSE was aware of the situation and of Vicky's case and did nothing about it, how would that make her feel?
Ms Vicky Phelan:
I was in work when I got that phone call and literally my legs nearly went from under me. Cian said it took himself and Siobhan a while before they rang me. It was shocking. I thought it was just me. Even when it was just me and that information was withheld from me, I was never going to sign a non-disclosure agreement just for myself because I thought it was outrageous that I was not told, but when I heard there were 14 other women that was it for me. I could not sit on that information. I had to do what I had to do to make sure those 14 other women found out. It is simple as that.
With regard to those national directors who were actually made aware of Vicky's case - and different information is coming out as regards 2016 and 2017 in particular - between 2017 and Vicky actually blowing the lid off this only a few short weeks ago, they were not active in respect of this information. They have done nothing with it and have not said that it has to be dealt with. This is not just one person.
Ms Vicky Phelan:
No, and the shocking thing about all of this - and it probably answers the question Catherine asked about the confidentiality clause - is that I think the laboratory's barristers and solicitors, not the State Claims Agency because it seems to have been led and said by the laboratory, to be honest, in my case, were hoping they were going to get a sick woman-----
Ms Vicky Phelan:
They were hoping I would settle and sign off on a non-disclosure agreement, and just go off and never be heard from again. That confidentiality clause is included in the laboratory's contract. The State Claims Agency said there was nothing it could do because this is part of the contract between the laboratory and the HSE. I totally disagree with that. I see now that the Taoiseach said another nine cases are pending where the State Claims Agency is going to stand in and get indemnified against the laboratory, which I am glad to see, but why, in my case, did it try to fight it? That is what I would like to know.
My final question - I am prone to asking too many questions - is for Stephen and Vicky. People whose families have been affected and who have not gone public for various reasons will be in touch with them. Would they encourage others-----
Ms Vicky Phelan:
-----and interviews to keep this issue alive, my main priority is the other women. Apart from having to take the HSE and the laboratory to court to fight my case, I have been fighting for the drug I am on, never mind anything else. It took me nine weeks to get access to the treatment I am on because it is not licensed for my cancer. I am trying to help the other women to get access to these treatments because cervical cancer is not curable. If I had taken the treatment I was offered, which is palliative chemotherapy, I do not think I would be sitting here today to be honest.. Simon Harris has mentioned that part of the package will include access to experimental drugs, and I have pushed him on this. I have been in touch with him. He has confirmed that the drug I am on will be accessible to other women, but it should not have to be piecemeal. Most of these women are contacting me. These women should not have to be contacting me for this information-----
Ms Vicky Phelan:
-----there should be a forum or somebody. When I was diagnosed with terminal cancer, I had nobody to go to to find out information. I did it all myself, looking up clinical trials and experimental treatments. This should not have to be done by somebody in my situation. A patient advocacy service for cancer needs to be put into place that is independent of the hospitals and independent of the Government. That is one thing I would like to push for.
Mr. Stephen Teap:
-----so they can focus on the job in hand, which is their treatment, definitely the answer is "Yes". Given that Simon Harris cannot get the information from the HSE on the detail of these people, maybe there is another way we can do this.
If something was set up which the victims could contact anonymously we could capture the details of it.
Mr. Cian O'Carroll:
I want to make a small point of clarification on the contract indemnity and confidentiality mix. We have not seen the contract that is in place. I presume this committee will probably get that documentation. It is the indemnity which is in the contract and the indemnity is like any insurance indemnity that some sub-contractor would give to the person to whom they are contracted. Presumably, the contract does not contain any confidentiality clause. It is just that the laboratory, having given the indemnity to the State, is then running the proceedings and it insists on settling it on its terms. That is all.
I thank all three witnesses for coming in today. Everybody in Ireland owes thanks to Vicky, Stephen and anyone else who has come out on this issue and explained to us, from where we are, how it has affected them, their families and all those around them.
I want to home in on one particular aspect, which I believe Vicky said. It is the idea that it would not have made any difference. I keep thinking about her saying that. Who decides what a difference is? It may not have made a material difference to the outcome in some cases. It is difficult to quantify in some cases, although I am not saying in the witnesses' cases, but the fact that something has to have a change in staging for it to have made a difference is getting to the crux of the issue because we are ignoring the feelings and the considerations someone goes through when they have a diagnosis of cancer. They wonder what could have been if they had noticed something earlier. Vicky went through her symptoms in great detail, and I thank her for doing that. It is very difficult but it is important that we hear the actual detail of what she has gone through. However, it is important to acknowledge that in terms of families or individuals who have a cancer diagnosis, everyone will meet that news with a different reaction. The difference does not have to be a stage or a level in terms of how long they have got left. It is more to do with how they deal with it, and how they deal with it as a couple, in Stephen's case. It is very difficult for any of us here who have husbands and young children to consider how they would get on without us. In terms of the future, it must be very difficult for Vicky, with her diagnosis, to consider that it might not be her but those she may leave behind who will have to continue her fight.
Vicky mentioned the 12 months of wrangling with the HSE and laboratories. Like Deputy Kelly, I sit on both the Joint Committee on Health and the Committee of Public Accounts. So much has come out in the past week but I am almost sure that we were told that period of wrangling occurred between March of 2016 and the summer of 2016 and that was the reason for the line in the memorandum, "Pause all letters", or whatever it said. The justification I heard this morning at the health committee for that period was that this was dealing with that issue, but Vicky has told us she was wrangling with the HSE for 12 months. I do not want to put her under pressure but it is important because my understanding is that we were led to believe that this was a short period of a few months. Is it possible for Mr. O'Carroll to find out where that is coming from because it is important for tomorrow's meeting?
I am shocked at the way Mr. Teap was treated. I cannot believe the insensitivity shown in that people were brought into a holding area, for the want of a better term. We need to find out who in God's name decided in the past few weeks that this was the appropriate way to treat these people. I suspect it was not anybody with a medical degree, but perhaps I am wrong.
What comes to the fore in all of this is that people have a vocation. They are clinicians first and they see patients before they see data. We have a serious issue in our health service when somebody like Mr. O'Brien opens an email and decides, without his medical degree, that this is not a significant error. A committee, and I believe it should probably be the health committee, needs to get to the bottom of who decided that was the framework in which Stephen should be treated.
On the magnitude of errors, in Vicky's case, when the audit of the slide was done, it was essentially extensive cancer. It is becoming more alarming to me, as we find out more information, that the 15%, 20%, 30% or whatever was the acceptable level of false negatives or false positives was not a consideration. To my mind, we have not seen any evidence that anyone quantified those errors. Was it a systemic error in a particular laboratory? It is shocking to me that anyone could look at Vicky Phelan's case in particular and say, "Okay, we have this false negative." However, it is not really a false negative. It is active cancer on a slide. My understanding from the conversation around it is that they would not really need a microscope; it was that obvious. It seems to me that this would be fundamental to the audit process. If there was a 30% rate, they would need to make sure that it falls within the category of false negative and that it is not something extra to that.
We spoke about the auditing process at the health committee earlier and there seems to be a serious issue with that process. There seems to be many people in the HSE with the word "audit" in their job titles. One of the fundamental aspects of audit is that one should know what one will do with the results when they are received, and there should be a pathway. Critical to this is that there was no pathway decided before anything happened, so what was the point of the audit? It appears the point of the audit was data rather than people.
I hate giving round figures because everyone is a person in this but we have a figure of 1,500 and then 1,641 from the cancer registry. If we combine them we have approximately 3,000. That is the number of women with a diagnosis which have been audited. Of those, there are 209 in the first batch - excuse my terminology - and another number in the second batch. We do not know that number. In the case of the error on Vicky's smear, it seems obvious to me that an immediate random audit has to start of all of the samples, not just the approximately 3,000 women because all of those have cancer-----
-----but all the people in the system. I am not saying all of them should be looked at again. That is unreasonable, but in light of what Vicky has said today, that has to be done. I thank the witnesses.
I will ask Vicky and Stephen to hold responding to that because I want to call Deputy Jonathan O'Brien. I am conscious that if we start one to one questions and answers, we will be here far later. I did give a commitment to the witnesses, and they are being very good with their time, not to go beyond two hours.
That is why I want to group the questioners together in an effort to answer the two together. Otherwise, we will not be fair to the witnesses because they have been very fair to us.
I will go to Deputy Jonathan O'Brien and then ask you to answer that group of questions and then Deputies Cassells, Deering and Burke will be in the last group of questions.
The issue of MedLab was mentioned earlier, perhaps it was missed.
I will be very brief as we have already been here for two hours. I thank you for your testimony today. I do not know what else to say. It was difficult to listen to and as I can only imagine how difficult it is for yourselves and your families to go through this, I thank you.
I have a comment and two brief questions. My comment relates to what you said earlier about the wrangling period. My understanding was similar to that of Deputy Kate O'Connell, namely, that that period of disagreement between the labs concluded around May or June 2016. My understanding - and I will double-check tomorrow - was from the documentation we had received, which said that a meeting was requested between the national screening service and the labs. After that took place, all legal correspondence ceased.
My questions relate to some of the issues that we heard last week and on which I seek your views. Last week, representatives of the State Claims Agency claimed that they were completely opposed to the non-disclosure agreement which Vicky was being asked to sign. They said that under no circumstances did the agency support that. Can Vicky say whether that was communicated to you or your legal team? Perhaps Cian O'Carroll can answer that. When did either Vicky or Cian become aware that the State Claims Agency had taken the position that it was completely opposed to the use of a non-disclosure agreement in Vicky's case?
What sort of process was there in respect of obtaining documents? Was co-operation given to Vicky and her legal team up to this week? Can Cian say what the attitude has been by CervicalCheck towards releasing documentation to people, in his experience? Is there an open procedure to getting that information or is there still a culture of trying to put obstacles in people's way in terms of getting the documentation to which they are entitled?
It had been suggested to me by GPs that no matter where the examinations were done by MedLab, that they were getting results back that were signed by an Irish-registered pathologist. I wondered if, in the course of Mr. O'Carroll's investigations in Vicky's case, it had emerged that one of her tests had been done in this subcontracted laboratory. If this was the case, was it still signed off on by an Irish-registered pathologist?
Mr. Cian O'Carroll:
No, from the records the original misread smear from 2011 was sent to MedLab's sister company in Texas, namely, CPL Inc. It then sent back the result. I do not know if there was another version of that result which was then signed off on by an Irish pathologist. That is entirely possible. There was a subsequent review of that in 2014, which was conducted through the MedLab sister company, CPL, and that was signed off on by a Dr.Clelland who appears on both MedLab and CervicalCheck documentation.
Mr. Cian O'Carroll:
I do not know exactly, because these are the results that the doctor - the GP - would receive back. They are both on MedLab-headed paper. The 2010 one says that it was processed in Austin, Texas. There is a name at the bottom of them but I do not know where they are located. We still do not have Irene's medical files, I requested them two weeks ago tomorrow, so I still do not have any detail on it.
Can Cian say from his investigations, if that would be a case of transcribing the results from Austin or would that signing pathologist himself or herself have taken a look at a slide under a microscope?
Ms Vicky Phelan:
The reason I ask is because my audit was carried out in October 2014. What happened between then and March 2016, if that triggered this legal wrangling, up to July? What happened in that intervening period? I know that Gráinne Flannelly mentioned they were trying to come up with a communications strategy for the clinicians but did it take that long, between October 2014 and March 2016 when they were stopped in their tracks with this legal wrangling, for that to happen?
Mr. Stephen Teap:
I will make one comment in relation to what Kate said about auditing all women's last smears. I have also called for that but for two reasons, one of which is to alleviate the fear among the women of Ireland. They are terrified. When one hears Vicky's story, or Irene's story about two consecutive smear tests which have been misread and now she is dead, of course they are afraid. The Government and the HSE have a duty of care to alleviate women's fear and to do so quickly. Second, we do not know what the error rate actually is. There are so many different variations of what it is and we are being told by people who cannot back it up with any type of proof. As part of this investigation, we need to get our own proof on that and arrive at our own figure. We can only do that by doing our own audit of these. That is why I support what Kate said and those two reasons are why I think it should be done as a matter of priority.
Mr. Cian O'Carroll:
I would like to make one brief comment on Deputy O'Connell's question. She stated that the 3,000 women who have been diagnosed with cervical cancer over the last ten years, during the life of CervicalCheck, had been audited or subject to an audit. In fact the number is less than 500 - of those who have been subject to an audit and a review of their case.
It is important to be aware of that.
Mr. Cian O'Carroll:
There are 3,000 women who have been diagnosed with cervical cancer over the last ten years but, according to CervicalCheck's figures, fewer than 500 of those have been reviewed or looked back on by a second check of prior smears. The figures are quite complicated so it might be useful for the committee to understand how the numbers are broken down.
You have raised an issue and we are not sure about it. We will clarify it tomorrow when those people will be here. We cannot expect the three of you to be able to clarify it. We will park that question and it will definitely be on the list of questions for tomorrow.
Mr. Cian O'Carroll:
Certainly. Jonathan asked when I learned the position of the State Claims Agency. I probably would have learned it moments before my client. I hope I would operate an open disclosure policy between the two of us. I was not aware that it was the laboratory and not the State Claims Agency. We were not aware of that initially. It became apparent after the case was resolved when there was a press release to "Morning Ireland" a few days afterwards at the height of the media controversy. I accept that it was not at the request of the State Claims Agency. In fact, it would not be its form to seek confidentiality. We just did not know it was resisting that with the laboratory at the time. It is probably understandable that where there are co-defendants and multiple parties in a case, one is not going to come to us and tell us it is having trouble with the other. That is not typically the way it works. There is a united approach.
Mr. Cian O'Carroll:
It is a little problematic. In Vicky's case, we contacted CervicalCheck and explained that we needed the records urgently and it released them a day later. That was very important in progressing things urgently. As of last Friday, we had been looking for eight days for some people who, unfortunately, are in a similar situation to Vicky and need their cases progressed before the summer vacation at the end of July in order to have them resolved, because the courts are off after that for two months. Unfortunately, there was an incident on Friday when it was resisted by CervicalCheck in its Limerick office.
Mr. Cian O'Carroll:
Yes. I had escalated the query to some people in the Department of Health who had given me their contact details. They were very helpful, as was the new director of CervicalCheck. He instructed us that it was in order for us to send somebody to its office in Limerick to collect records. When the person got there, the person was told the records were not available and the person was escorted from the building.
I will call Deputies Cassells, Deering and Burke. This is the final group because I have given a commitment not to go on excessively. The three Deputies can make their observations and there can be a collective set of answers at the end.
First, I thank Vicky and Stephen for being here this evening. On a sunny evening such as this, I am sure that, as young parents, they would prefer to be playing with Amelia and Darragh or Oscar and Noah rather than be in a committee room in the bowels of Leinster House discussing this subject. We thank them for making the time available to give their accounts. Stephen said he wondered what Oscar and Noah would think ten years from now when they look back on this and on what their Dad did today. They will be very proud of what their brave Dad has done in standing up and talking for their Mum in Leinster House.
Officialdom has been given a fair crack of the whip in these committee rooms, week in and week out, but I am not sure if people listening are any wiser. The impact of its decisions, or lack of decisions, is a personal human story that is manifest in the stories of Vicky and Stephen, on behalf of Irene. Vicky spoke about the appalling breach of trust - on the day of her court case - on the steps of the High Court. As she has monitored proceedings over the past couple of weeks, has she seen anything that shows a willingness to change on the part of the people who are coming to this committee to answer questions or, as Stephen said, is the protect and deny culture still thriving even up to this point? The exiting director general of the HSE at the committee last week, and even after he was gone, was like a dying wasp with a sting in his tail.
He was tweeting about the people in this room and seemed to be more concerned about throwing that Scud than being involved in a process of engagement that could help. I would like to hear Vicky's reading of that situation and those comments and her thoughts on whether a protect-and-deny culture is still endemic. Is that fuelling her request for a complete clear-out to allow for an honest appraisal of the situation, rather than protecting an entity? God knows what they are protecting.
I am interested in the question Cian posed about the magnitude of the errors. The discussion has been focused on the lack of communication, but you made an interesting point in terms of focusing on the magnitude of errors and why there is a closed-mind attitude to the latter. How far do you think that closed-mind attitude permeates the system? When the Taoiseach was addressed on this matter during Leaders' Questions on 1 May, he said it is just the norm that two pairs or four pairs of eyes miss something like this. However, as Vicky said, it was not a small amount of cancer but, rather, a slide full of it. I would like to hear the witnesses' views on that substantive issue.
I welcome Vicky, Stephen and Cian and thank them for appearing before the committee to tell us their heartbreaking story in graphic detail. Obviously, the past period of time has been very difficult for them. I recall a certain individual a number of years ago making the point about another person who had passed away that he had done the State some service. There is no doubt that Vicky, Stephen and Cian have done the State a great service over the past couple of weeks. They have become the catalyst for something everybody in this room and many people in Leinster House have been seeking in recent years, namely, reform of the HSE and the health service. As a result of what they have done I believe we will never again see the same attitude in the future.
I wish to raise two points arising from the presentations. One was mentioned by Deputies Cassells and Kelly and I wish to tease it out further. It is about the same people still being in position as we move on. I believe there must be accountability not just in the House but across the board. Vicky, Stephen and Cian will be aware that there are a number of investigations taking place. We all want to get to the bottom of this issue. We need to get all the answers. Would it be better if the five, ten, 20 or whatever number of people are involved were left there to get the answers rather than move them to one side at this stage? I have no preference regarding the answer to that.
Second, Stephen made a point that refers to both him and Vicky. First, you said it is disappointing that you still have not heard anything about the suite of services and supports that was announced on Friday last. Do you think there is enough there? Stephen might have mentioned that there are other issues that could be addressed in the future. You are both in different situations to a certain extent. What other services are required over and above what has been announced in the past couple of weeks?
I wish you both every success and good wishes for the for the future.
I would like to thank Vicky, Stephen and Cian for attending. I think Vicky and Stephen have shown great courage in giving their testimony. It is very much appreciated. As other speakers have said, I think it is going to be of huge service to other women, and will ensure that we do get the truth. Over the course of this discussion we have got very valuable information that will help us in questioning the other individuals who will be coming before us. I wish to raise two things very briefly. First, anyone with a basic knowledge of statistics would know what a false negative is. However, the chances of an individual getting a slide wrong twice, in two separate tests, are non-existent. That is what really worries me here; the incompetence. As you said, were they looked at at all?
The second thing concerns the State Claims Agency. Its representatives said that they were very vociferous, although maybe I am quoting them incorrectly, in their fight against non-disclosure agreements. Is that a sense that you got from your interaction with them?
Finally, everyone is very proud of you both. I know from watching her interviews that your family has been incredible. Your television appearance on Saturday night was an incredibly brave and courageous interview. Most importantly, I hope that from all this and from your treatment your get a good sense of hope. It is very important to have hope for the future, and I hope that you progress well.
Ms Vicky Phelan:
Peter asked about the State Claims Agency fighting against non-disclosure agreements. One of the things that really actually enraged me with my case, when it did settle, is this. I got to a point where they were going to waive the confidentiality clause because they knew I was not going to sign one. However, what happened in that case was that the HSE was struck out. It was absolved of all responsibility and did not have to admit any liability, because we were looking for exemplary damages. The HSE officials knew that if they got caught there would be a rap on the knuckles and they would have to pay for it. I have a huge issue with this. I know there was a trade-off, according to what Cian was telling me. I do not understand the ins and outs of legalities. However, he will tell you; I really wanted to keep going, to be honest. I did not want the HSE to be struck out because I wanted it to be made accountable and to admit liability, but I was never going to get that. There was a trade-off.
Mr. Cian O'Carroll:
-----picking through documents. In regard to the point that she makes about the HSE, there were two defendants in the case. There was a negotiation. There was one fundamental that my wonderful client had set from day 1, which was that there could never be a confidentiality clause. Eventually, when that was surrendered by the defendant - I thought it was the defendants, until we found out later it was just the laboratory - then a negotiation began. That was after three days in the High Court. It was six days after the case had started. The focus then was on the terms of settlement. As part of that, the HSE was to be let out of the case. There was nothing, apparently, to be lost or gained from doing that. I almost feel I am confessing and apologising to Ms Phelan. Maybe in hindsight, if we were to go back now, knowing what we know and what has happened, it would be tidier to keep the HSE in it. The HSE admitted in their defence to a breach of duty in a partial delay of informing Ms Phelan in 15 months of what had happened, which is extraordinary. A party has been let out of proceedings, and yet it makes an apology, publicly, for the actual liability issue that the proceedings were about. I do not think I have ever seen that before. In that sense, the HSE was not let out. It was let out, but it ultimately had to apologise to Ms Phelan.
Mr. Stephen Teap:
Deputy Deering raised two questions about the people that are in key positions. He asked if they should be left to answer the questions. I think they have clearly proven time and time again that they are incapable of passing on information, currently, with regard to questions they are being asked. What I was saying was that they should be removed, and we just need to get the answers through investigations. However, I would not let them go too far. They still face questions that need to be answered.
With regard to support services and whether we have done enough, I think that as long as we can implement everything that was said last week, we will have done enough in the short term.
Mr. Stephen Teap:
However, it needs to be done quickly, and it will be a week this Friday before it is announced. It needs to be proactive, and people need to be reached out to. There is no point in displaying a number on a wall and directing people to contact it. They need to be reached out to. We do not know the scale of how sick some of these women are. We do not know the situation of all of the families that are in my position, that have lost people, and where they are today. In the short term we need to act fast, but there certainly needs to be some sort of review on a long-term basis.
I think at this stage there is just one final point. I want Mr. O'Carroll to clarify something, because we are all a little bit taken aback. People thought there were 3,000 cases of cervical cancer. Is he saying that only 500 have been audited?
Mr. Cian O'Carroll:
The statistics have been dripping through. It started with the interview given by Gráinne Flannelly, then clinical director of CervicalCheck, on "Morning Ireland" on 25 or 26 April. We first got a sense of statistics then, when she explained that there were 1,462 cases that had been looked at. Of those, a cohort selection of 460-odd cases had been sent for review. Of that, there were 209 cases - it was about 206 then, but the number has since grown - which involved an error in the reporting, which resulted in a clinically significant delay in the commencement of treatment for the cancer. That is the crucial bit. We then found out that there were another 1,500 on the national cancer register, and that brought the total figure of women who had been diagnosed with cervical cancer over the ten-year life of CervicalCheck to date to 3,000.
However, the documents that were released last night from the Department of Health include some of the annual reviews and audits which were happening around the CervicalCheck programme. In the review, the statistics for 2016 show that at that stage they had only audited about 400 cases. The current figure is somewhere around 462. That is the figure that Gráinne Flannelly gave. It explains why not everybody is being audited in this report. It shows that the service categorised cases by the timing within the history of the cancer. They categorised the timing into six different categories. For example, among women who had a diagnosis following a previous colposcopy, only most of the cases were reviewed and looked back at. None of the cases where there was no screening for the woman prior to diagnosis of cancer were reviewed or looked back on.
Mr. Cian O'Carroll:
I refer to any smear that was taken prior to 2008. For example, Vicky had a smear in 2007. CervicalCheck never looked back on that. Even though it found a very significant error in the 2011 one. It had no interest, and what the organisation's spokespeople have stated is that there is nothing to be learned by them from looking at smears which predate the inception of CervicalCheck.
Ms Vicky Phelan:
I just wanted to answer Shane's question on willingness to change. That is why I am here. Do people think I want to be here? If I do not have a huge amount of time left I certainly do not want to be spending it up here in front of committees. I am here because I want to see change happen, no more than Stephen who should be at home with his two boys. We want to see change happen because we never want to see this happening again. Stephen and I should not know each other, and I do not mean that in a bad way. Look at why we know each other. It is horrible. Stephen and I met for the first time today and it was very difficult for both of us. We have been in touch with each other over the phone but we had not met before today. We are here because we want to see change. I swear to God over my dead body unless I see something happening I will keep at this and it is as simple as that.
On that note I will bring the meeting to a conclusion. I thank Vicky and Stephen very much for their evidence, which has been very helpful not just to us but to everybody who is listening in. Lessons will have to be learned if their situations are to mean anything at all. I also thank Cian for his assistance here today. I thank the witnesses very much indeed.