Caroline O’Doherty answers the key questions from the cervical cancer scandal.
Q. What is CervicalCheck?
A. It’s the national screening service that invites women aged 25 to 60 to attend their GP or a designated clinic for a free smear test every three years to check for possible signs of cervical cancer.
Q. What kind of signs?
A. Screening is designed to pick up abnormalities or changes to the cells of the cervix which can be a precursor to cancer. If significant changes are detected, the woman may be referred for a more detailed examination called a colposcopy to see what, if any, treatment is warranted. The test is not designed to catch already existing cancer although it may do so.
Q. What’s the take-up rate?
A. Since it was established in 2008, the numbers of women accepting their screening invitations have risen year on year so that some 80% of women due a smear test in any given year now have it. That’s more than 270,000 women a year.
Q. What are the results in an average year?
A. About 90% of smear tests are declared normal. Around 18,000 women will be sent for colposcopy because something of concern or interest has shown up. About half of those will be found to have pre-cancerous abnormalities. Most will undergo treatment as an outpatient while some will not need treatment yet but will be scheduled for a repeat test within a year. In 2016, the last year for which we have an annual report, 187 women who went for screening were diagnosed as already having cervical cancer.
Q. How accurate is the test?
A. It depends how it’s used. It does throw up false positives which are not a problem medically although they may cause distress to some women who will have to have a colposcopy before getting the all-clear. But it can also give false negatives, particularly if the sample is not examined in sufficient detail.
Q. Surely they should all be examined in great detail?
A. That depends on the system adopted. Ireland has been using two US-owned laboratory companies — one in the US and one based in Ireland — to examine the smears but in the US, women have traditionally been screened every year. So if a tiny abnormality is missed in screening the first year, it is likely to be more visible in year two and it will be picked up there before it has developed into a serious problem.
However, if a tiny abnormality is missed in year one here, it may have developed into a serious problem three years later. In the last few years, US health authorities have been advising that testing every three years is sufficient but it is not clear how far that has altered personal habits or the thoroughness of testing.
Q. Were any concerns about the differences between the US and Ireland flagged before the CervicalCheck contracts were awarded?
A. It was pointed out in 2008 by numerous doctors whose concerns were backed by numerous politicians including Dr James Reilly, the then Fine Gael TD who went on to become minister for health, but the arrangement proceeded anyway on the basis that there was insufficient capacity in Irish labs to take on the job. One Irish lab now does share the work.
Q. So have abnormalities — and the chance to stop them developing into cancer — been missed?
A. Yes. The problem came to light with Limerick woman Vicky Phelan, who was diagnosed with cervical cancer in 2014, questioned why her 2011 screening did not flag a problem. It turned out the abnormalities were present in 2011 but were not detected. However, they were detected during a follow-up audit of tests in 2014 but she was not informed of this until 2017 after she sued a US lab. We now know that 208 other women had abnormalities that were only detected during follow-up audits and 175 cases would have been “escalated” for follow-up action had the abnormalities been detected. Of the 208 women, 162 were not informed. Since the scandal broke, 172 have been informed and efforts are ongoing to contact others , but 15 women died without being informed while two women who were informed also died.
Q. Why were they not informed?
A. The audits were carried out primarily for training and quality assurance reasons and there was no clear policy on informing women. In Vicky Phelan’s case, there was a dispute between her doctor and CervicalCheck over who should inform her which led to a stalemate for several years.
Q. Is 208 the full extent of the women affected?
A. Nope. We learned on Monday that not every questionable test was given a follow-up audit. At least 1,500 other women diagnosed with cervical cancer over the past 10 years did not have their cases reviewed to see if they were previously screened and, if so, if that screening should have led to an earlier cancer detection.
Q. Why did we not know about the other 1,500?
A. These cases were notified to the National Cancer Registry, but not to CervicalCheck. CervicalCheck say they have a policy of sharing data with the registry because they ask women for their consent to do so but that isn’t reciprocated by the registry. CervicalCheck says they are now working on a data sharing partnership with the registry.
Q. So could there be at least another 208 women out there who might expect to receive a call to say something was missed?
A. CervicalCheck thinks it will be a smaller figure than that as some cases will have originated before 2008 so the women will not have been tested at all before they developed symptoms of cancer.
Q. What happens now?
A. All women who were diagnosed with cervical cancer and had been previously screened are to have their tests checked to see if something was missed. There is also to be a statutory inquiry into the scandal. Also, a new test, which has been promised for years, is to be introduced later this year which, we are told, gives much clearer results than the current smears used.
Q. What should women who have used Cervical Check do?
A. Any woman who has concerns about her smear test and wants a new test can get one for free, or have her last test rechecked. However, the arrangements for this have not been notified to GPs and clinics yet as the logistics of dealing with demands for GP consultations, fresh tests or rechecks are still being worked out. Notices are expected to be issued later this week.
Q. What if a woman has a scheduled routine smear test coming up?
A. That appointment still stands and the advice from CervicalCheck is to go ahead with it.
Q. Will the same labs be used to test the smear?
A. It appears so. The contracts have some way to run yet and it’s unlikely they would be terminated in advance of the statutory inquiry. However, the contractual relationships will be under pressure — there are six other claims lodged in the High Court against the HSE and the lab companies, four more expected to be lodged and one other potential case. So far.