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The following is the redacted version of a briefing note about Vicky Phelan’s High Court case sent to Minister for Health Simon Harris on April 16th. It was released by the Government on May 1st.
PDF version: http://health.gov.ie/wp-content/uploads/2018/05/0864_001.pdf
CervicalCheck: Patient claim following a diagnosis of cervical cancer
Briefing Note for Minister Harris
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Issue:
A patient is taking a case against the HSE (National Screening Service CervicalCheck) and Med Lab/Clinical Pathology Laboratories Ltd, the company providing cytopathology for CervicalCheck.
In May 2011 the patient received cervical cancer screening through CervicalCheck; no abnormalities were reported.
A subsequent (routine) screening through CervicalCheck in June 2014 detected high-grade abnormalities and the patient was diagnosed with cervical cancer in July 2014.
The patient’s case is (i) that the 2011 screening test was falsely reported as negative and that the test was in keeping with a diagnosis of “query squamous cell carcinoma” and (ii) in relation to the non-disclosure of a CervicalCheck standard review process (clinical cancer audit) and of the outcome of this.
The State Claims Agency (SCA) is managing the case on behalf of the HSE. It has advised that:
i) liability for the 2011 screening test tests with the laboratory only (as per HSE contract with the lab, and as acknowledged by BLM solicitors, representing the lab);
ii) the SCA is of the view that a claim for exemplary damages in relation to the non-disclosure of the CervicalCheck standard review process is likely to fail/be dropped, in the absence of any evidence of bad faith by the HSE in this regard.
Mediation discussions between the patient and the laboratory were held on Monday 9th April. The SCA informed the Department that no agreement was reached; the laboratory’s insurance company required complete confidentiality as a condition of any settlement and this was not acceptable to the plaintiff.
Pre-trial discussions with a judge took piece on 10th and 12th April; the matter may progress to the High Court on 19th April.
The SCA has advised that they understand that BLM solicitors endeavour to settle the case on the best possible terms. in its view the case is likely to be settled shortly before going to court. The SCA is of the view that publicity around the case and/or settlement is likely.
Background
[Text has been redacted]
CervicalCheck initiated a clinical cancer audit of the patient’s case, as per protocol for all notified cases of cervical cancer, in September 2014.
As part of the audit the initial cervical cytology test taken in 2011 was reviewed. [Text redacted]
The clinical cancer audit was closed in December 2014.
At the time in 2014, the outcomes of clinical cancer audits were used by CervicalCheck for education and training purposes only. (See Appendices)
HSE Position
BLM solicitors have shared a copy of an expert report with the SCA which we understand will form part of the laboratory’s defence in the context of liability and causation.
The report was prepared by Tim D Feit, Member of the University of Wisconsin, Madison Cytotechnology Advisory Committee.
[Text redacted]
The National Screening Service and Jerome Coffey, Head of the National Cancer Control Programme, have advised the Department in writing that they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test.
The current primary screening test used by CervicalCheck is a cytology test which is known to have low sensitivity (60%-75%) i.e. it produces a not insignificant number of false negative results. This known limitation of the test is one of the reasons for screening women at regular intervals.
A switch to HPV testing as the primary screening test in CervicalCheck has been approved and will be introduced in late 2018. The accuracy of primary HPV testing is significantly higher than the current liquid-based cytology testing and will therefore result in fewer women receiving a false negative result.
The National Screening Service has assured the Department that no quality issues have arisen in relation to the US laboratory which performed the 2011 test. (Under current contractual arrangements with CervicalCheck, MedLab carry out their work through a laboratory in Ireland. )
All laboratories that work with the programme, in addition to being accredited by national authorities, must comply with the programme’s quality assurance guidelines.
CervicalCheck monitors the performance of individual cytoscreeners on a regular basis to ensure that any variation in individual practice is identified and followed up appropriately.
When CervicalCheck is notified of a cervical cancer diagnosis a standardised review process (clinical cancer audit) is undertaken.
The Department is in consultation with the HSE in regard to their preparation of a press statement on the matter.
Suggested Quote for the Minister (if required following conclusion of legal proceedings)
“I acknowledge the severe distress that this issue has caused to the patient involved, and to her family.
Cancer screening programmes, offered through the National Screening Service, aim to detect cancer as early as possible, leading to better treatment options and outcomes for patients.
CervicalCheck has detected over 50,000 pre-cancerous changes in women since 2008, but no screening programme can prevent all cases of cervical cancer.
I recently approved a proposal from the National Screening Service to move to HPV testing as the primary test for cervical cancer from October 2018. HPV is associated with 70% of all cervical cancers and I would stress to women the importance of CervicalCheck and the HPV vaccination programme as key measures in reducing their risk of developing cervical cancer.”
[Name redacted]
Cancer, Blood Organs Policy Unit
16 April 2018
APPENDIX 1: Background Information
CervicalCheck Programme
Each year approximately 250,000 women have a cervical cancer screening test (smear test) through CervicalCheck.
Cervical cancer screening aims to reduce the incidence and mortality from cervical cancer. Incidence of cervical cancer in Ireland has fallen by 7% annually since 2010.
Cervical cancer rates in lreland have dropped from around 14 per 100,000 in the period 2009-2011 to 10 per 100,000 in the period 2013-2015.
Clinical Cancer Audit Process
When CervicalCheck is notified of a cervical cancer diagnosis a standardised review process (clinical cancer audit) is undertaken.
A clinical cancer audit examines the records of every woman diagnosed with cervical cancer who has been screened, or received treatment through CervicalCheck, in an effort to learn how cancers are diagnosed and develop.
At the time of the clinical cancer audit in question, such audits were intended for use in supporting continuous process improvements and in supporting education and training only.
In 2015 a decision was taken by the HSE, in line with international best practise, to provide information on outcomes of clinical cancer audits to treating clinicians for onward communication to patients as appropriate.
The outcomes of all current and historical clinical cancer audits were subsequently communicated to treating clinicians in 2016 (including this case).
More recently, women are informed of this audit process and they have the option to request information on the outcomes of these reviews, which are sent to the treating doctor for discussion with the patient.
Screening Test (CervicalCheck)
The cervical screening test is not a diagnostic test, it is a screening test. It is a test to indicate the possibility of precancerous or cancerous lesions and to identify women who require further investigation or follow-up.
Reasons that the screening test may not always identify abnormalities include:
Abnormal cells might not be represented in the cytology sample or the sample may have very few abnormal cells.
Sometimes abnormal cells can look like normal cells.
Certain cytological patterns and abnormalities are difficult to recognise.
The inherently subjective nature of differentiating normal from abnormal cells or level of abnormality.
The National Screening Service has advised that no screening incident has been identified here; the results arise from the limitations of primary cytology-based screening.
HPV Testing
The Human Papilloma Virus (HPV) is responsible for 70% of cervical cancers.
In March, the Minister approved a switch to HPV testing as the primary screening test in CervicalCheck on the recommendation of the National Screening Service.
The accuracy of primary HPV testing is significantly higher than the current liquid-based cytology testing; primary HPV screening will result in fewer women receiving a false negative result compared with primary cytology-based screening.
Testing for the HPV will virus also be a more appropriate strategy for the cohort of women who have received vaccination against HPV.
This proposed change is in keeping with developments in other high-income countries. Australia, Italy, the Netherlands, New Zealand, Sweden and the UK have all recommended the implementation of primary HPV screening.
Pembrolizumab
The patient has received considerable media coverage in relation to her illness, particularly in seeking access to clinical trials in the USA for Pembroiizumab (an immunotherapy drug).
She has fundraised through a ‘GoFundMe’ account to pay for access to the treatment.
This drug is not authorised by the European Medicines Agency (EMA) for cervical cancer and the NCCP [National Cancer Control Programme] have confirmed that there are no open clinical trials for this drug in cervical cancer in Ireland.
Primary Care (Community, Pharmacy, Dental, Optical Aural Policy Unit) have advised that:
Pembrolizumab is approved for the treatment of advanced Melanoma and is
reimbursed for same by the HSE i.e. it is available and reimbursed for that indication since 2016.
An assessment/application is on-going for the use of Pembrolizumab in 1st both line and 2nd line non-small cell lung cancer, bladder cancer, Hodgkins lymphoma treatment. There are no other uses for which market authorisation has been approved in Europe to date.
In relation to cervical cancer and cancer of the lymph nodes, the HSE understands that clinical trials are ongoing internationally and in due course it is likely that an application for market authorisation may be made to the European Medicines Agency for market authorisation for specific forms of cervical cancer and cancer of the lymph nodes. To the best of our knowledge no application for market authorisation has been made as yet for use in cervical cancer and cancer of the lymph nodes.
The HSE would not expect an application for reimbursement for this indication before 2021 at the earliest.