The news that the number of women affected by the CervicalCheck controversy may be higher than the 221 people currently identified is likely to cause considerable alarm.
Once again, it seems, the numbers are shifting, in a further underscoring of the absence of reliable data that has been a feature of this controversy since April.
At the height of the controversy in the spring, the HSE was at first unable to say just how many cases existed where the audit of the CervicalCheck programme showed the woman’s test could have provided a different result.
Eventually, it settled on a number of affected women – 209 – but this number crept up so that by July it stood at 221. Now, it seems almost certain the total will rise further, according to Dr Gabriel Scally, the Northern Irish public health specialist who led the scoping inquiry into the controversy.
Why is this happening? The background is that, as Dr Scally noted in his report published last month, “a complete presentation of audit outcomes has been impossible to locate”. Estimates are being drawn on the basis of incomplete information, it seems.
More specifically, an issue has arisen as to the criteria used by the HSE to determine whether women should be included in the “group of 221” patients (as it currently stands) whose outcome may have been affected by a false negative smear test.
When CervicalCheck carried out a review in 2015, screening tests that were carried out more than 18 months before the date of a woman’s cancer diagnosis were held to have potentially influenced the management of her treatment. So if the test produced a false negative, the outcome for the woman could have been different.
‘Flawed’ decision
Dr Scally said in his report last month that the decision to view 18 months as the cut-off for clinical impact was “undoubtedly flawed, and it is hard to see the logic for this”.
“Considerable tumour progression can occur over this timescale with potential impact on the stage [of cancer] and mortality,” he wrote.
He repeated the point at the Oireachtas health committee on Wednesday and revealed that he still doesn’t know whether the HSE used this criterion, or some other one, in determining whether women would be included in the “group of 221”.
Contacts are continuing with the HSE to ascertain the methodology actually used, but in any case the review currently being undertaken by the Royal College of Obstetricians and Gynaecologists of about 3,000 smear test slides is almost certain to throw up new cases. This is because it is examining a greater number of tests than were ever looked at by the HSE.
It is important to make the point that we are not looking at any new cases of women receiving a cancer diagnosis, but in some instances a test could have provided a different result.
Almost six months on since this scandal broke, many questions have been answered in Dr Scally’s report but troubling issues remain to be resolved. Auditing of tests within the programme has been put on hold, a backlog of smear tests is building, the future of the screening programme is threatened by mounting litigation and the HSE has yet to reach agreement on a new contract with the main laboratories that carry out the test.
Thankfully, given the crucial role the screening programme plays in identifying cancer cases early, take-up has not been affected by the controversy. It seems inevitable, however, that more women will continue to be affected.