The National Screening Service informed the Health Service Executive in March 2016 it would be preparing a media response for headlines stating "screening did not diagnose my cancer" in response to an audit of cervical cancer cases.
In the same memo, it confirmed it would be pausing the distribution of letters to individual clinicians advising them of the audit results conducted into their patients’ cases and awaiting the advice of solicitors.
Instead, the NSS said it would “decide on the order and volume of dispatch to mitigate any potential risks” and yet would “continue to prepare reactive communications response” for stories that might break in the media on the findings of the audit.
Three memos on what the HSE was told in 2016 about the cancer audits which are now the subject of a non-statutory inquiry were sent to the Oireachtas Public Accounts Committee on Thursday. HSE director general Tony O’Brien confirmed he read all three.
The cervical cancer smear scandal emerged after the case of Vicky Phelan, who secured a €2.5 million High Court settlement against US-based Clinical Pathology Laboratories, which missed her cervical cancer when it examined her 2011 smear test on behalf of CervicalCheck.
Ms Phelan was diagnosed with cancer three years later, and a 2014 audit showing her original smear test to be inaccurate – but she was not told until September 2017.
It subsequently emerged that audit of smear tests showed that 209 women could have received an earlier intervention and 162 of them were not told the outcome of the audit. Of the 209 women, 17 are dead.
Mr O’Brien has said he did not know about the Phelan case and its wider implications until her case was settled and she spoke outside the High Court two weeks ago.
Communication ‘risk’
The first memo given to the PAC is dated March 2016. It states the process is approaching the stage of communicating the results of the review with clinicians looking after women diagnosed with cervical cancer.
It states: “There is always the risk that in communicating individual case reports to clinicians of an individual patient reacting by contacting the media if they feel that ‘screening did not diagnose my cancer’.”
The memo goes on to say there is a “batch/accumulation of clinical audit case reports that have been completed”.
“The volume element of letters increases the risk of an individual reacting to the content if/when shared by their attending clinician. It is far from certain that this would happen.
“All international screening programmes will have encountered a media headline that ‘screening did not diagnose my cancer’.”
At no point in the memo does it make reference to a necessity to inform women of the results of the clinical review.
Instead, it reveals that one of the laboratories involved in reading the smear tests has sought legal advice as to whether the CervicalCheck programme has the right to communicate the audit review findings to clinicians. It noted under “next steps” to “pause all letters” and “await advice of solicitors”.
A second memo, dated July 2016, was compiled by Simon Murtagh, the then acting head of the National Screening Service. It was also sent to the HSE and Dr Tony Holohan in the department.
It refers to the decision to audit what was then 1,100 cases of cervical cancer that had been notified to CervicalCheck over a 7½-year period. It has since emerged the final audit examined a total of 1,482 cases from 2008 to 2018.
The main part of the memo says the audit process showed that “while the majority of cancers were detected as early as possible through cervical screening, not all cancers were prevented”.
It said: “To date, a total of 56 letters have been issued to treating clinicians for cases where cytology was reviewed and a further 200 letters will issue during July/August where cytology was reviewed. This will complete the communication of all historic cases in the early years of the screening programme (September 2008-2014). Given the volume of letters that will be issuing over the coming weeks, it is possible that individual cases could appear in the public domain. All international screening programmes will have encountered a media headline that ‘screening did not diagnose my cancer’.”
Trawl of records
It again referred to a threat of legal action from a laboratory over the audit findings but said this correspondence had now ceased.
This memo was shared with the Department of Health. A spokesman for Taoiseach Leo Varadkar, who was minister for health in March 2016, said he was not aware of this memo when in office.
The spokesman said Mr Varadkar had asked the secretary general of the Department of Health, Jim Breslin, to conduct a trawl of records to assess if his recollection is incorrect. That has not been completed and the spokesman said he was unsure when it would be.
The Department of Health later confirmed the Taoiseach was not aware of the memo but the chief medical officer Dr Holohan and one other senior official were aware of its existence.
A further memo was prepared for the HSE in July 2016 and was written by John Gleeson, CervicalCheck programme manager of the National Screening Service.
It did not include the briefing note referring to the media strategy or the decision to pause the distribution of letters.
It does outline that over 1,200 cases of cervical cancer have been reviewed to date and were related to the almost eight-year period of CervicalCheck’s operations. The memo confirms 30 per cent of the total notified cases have been flagged for a review. However, it does state: “All international screening programmes will have encountered a media headline that ‘screening did not diagnose my cancer’.
“The CervicalCheck Programme has prepared communications materials to ensure transparent, effective and robust communications processes are in place so as to provide clear information for the media and the public where appropriate on the CervicalCheck clinical audit process and results.”
“A ‘communications protocol’ has been prepared for consulting clinicians to address their questions.
"The spokesperson on matters related to this audit is Dr Grainne Flannelly, clinical director, CervicalCheck programme."
She resigned after the controversy broke last month.
This memo said: “To date, a total of 86 letters have been issued to treating clinicians for cases where cytology was reviewed and a further approximately 200 letters will issue during July/August 2016 where cytology was reviewed. This will complete the communication of all historic cases for the early years of the screening programme (September 2008-2014) in addition to recent cases (2015-2016) as the review findings become available.”
This memo was sent to the Department of Health and Dr Holohan and another official had access to it. Minister for Health Simon Harris has said he did not see that memo in July 2016.
