Emma Mhic Mhathúna was a 37-year-old Irish mother of five who died on 7 October 2018 from cervical cancer – an easily diagnosed and treated cancer if discovered early. She died because of a cervical smear scandal in Ireland that led her to receive a false negative on her two pap smear tests in 2016 as a part of the CervicalCheck program run by Ireland’s Health Service Executive (HSE), which manages Ireland’s healthcare.
As a result of this cervical smear scandal, Ms. Mhathúna sued the HSE and the US clinical laboratory, Quest Diagnostics, which performed the tests. She settled in court for €7.5 million from HSE and Quest. Another US-based clinical laboratory, Clinical Pathology Laboratories (CPL) of Austin, TX, was involved in a similar lawsuit from another Irish woman, Vicky Phelan, who also received a false negative – they settled for €2.5 million.
Ms. Mhathúna’s death was both tragic and a cautionary tale about relying upon the results of this test.
Cervical smear test primer
The Pap test is named after the inventors, doctors Georgios Papanikolaou and Aurel Babeș. It is also known as the Pap smear, cervical smear, cervical screening, or smear test (see Note 1). It is a method to screen cervical cells to detect potentially pre-cancerous and cancerous cells in the cervix, the opening of the uterus. If these cells are found, the woman is usually directed to follow up with more diagnostic procedures to eliminate false positives or proceed with the treatment of cervical cancer.
The cervical smear test, when combined with appropriate follow-up, can reduce cervical cancer deaths by up to 80%. Unfortunately for Ms. Mhathúna, the false negative of her test meant she did not get the opportunity for appropriate actions to treat her cancer.
The actual test is performed by a physician collecting cells from the outer opening of the cervix where squamous cervical cells are found. After collecting the cells, they are sent to a clinical laboratory, like Quest Diagnostics or Clinical Pathology Laboratories, to be examined under a microscope to observe whether there are abnormal cells or not. The cervical smear can potentially find pre-cancerous cells called cervical intraepithelial neoplasias (CIN), known as cervical dysplasia.
There seems to be some misunderstanding that cervical smears are examined by the physician who collects the cells. In fact, the tests are almost always sent to a commercial clinical laboratory or local hospital laboratory for examination by a pathologist.
Cervical cancer primer
The most important risk factor for cervical cancer is an infection by the sexually-transmitted human papillomavirus (HPV). There are at least 147 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Of those 40 strains, most are fairly rare – HPV types 16 and 18 are, by far, the most common types linked to cervical cancer.
The virus causes over 43,000 cancers a year in the USA, including, according to the CDC, nearly 12,000 cervical cancers every year.
The Irish cervical smear scandal
In 2008, the Irish HSE began CervicalCheck,“a quality-assured, organised and population-based screening programme” to provide free cervical screening to women aged 25 to 60. The CervicalCheck women’s charter says the service is “committed to providing a safe and reliable service to women.”
In 2008, the HSE awarded a contract to Quest Diagnostics to examine the tests followed by a 2010 contract to Clinical Pathology Laboratories. A hospital in Dublin also was involved in the testing but lacked the ability to process so many tests at one time.
Here’s where the problem started. According to Dr. David Gibbons, the former chair of the cytology/histology group within the quality assurance committee of the National Cervical Screening Programme, argued that US labs have a 1/3 lower detection rate for abnormal cells than those in Ireland. Although this is horrific for over 200 Irish women who may have received false negatives, think about what this means for women in the USA. There are hundreds or thousands more tests done on American women (as a result of a substantially larger population) – this could mean thousands of American women who have false positives.
Dr. Gibbons resigned in April 2018 because his findings were ignored.
It’s difficult to say whether Quest and CPL are incompetent, unethical, or both. Quest Diagnostics has a long history of illegal and unethical behavior:
- In 2009, Quest had to pay $302 million to Medicare to settle a whistleblower case against the company in which the company sold faulty medical testing kits to Medicare.
- In 2011, Quest had to pay $241 million to the state of California to settle a False Claims Act case in which they had overcharged Medi-Cal, the state’s Medicaid program, for clinical laboratory testing. They also provided illegal kickbacks as incentives for healthcare providers to use Quest labs.
This kind of history of malfeasance makes me wonder why Ireland would choose Quest to provide the testing services. Even if I were to ignore their previous unethical behavior, their incompetence in this testing is beyond excuse.
Although I do not have intimate knowledge of Quest’s procedures, I have a thorough knowledge of the clinical testing industry. Most clinical tests are highly objective – if you are being tested for cholesterol, an automated machine detects the actual amount of cholesterol in the blood sample and provides a numerical value. As long as that machine is well-maintained and -calibrated, the results are fairly accurate within a narrow range.
On the other hand, cervical smears are much more subjective. The cells have to be examined under a microscope by a technician. Or an image from the microscope is sent to an offsite (or even offshore) group of technicians to review those images.
And the results from those analyses are influenced by everything from fatigue to incompetence to bad images. What really matters, however, is that those false negatives lead to a woman’s false relief from a cervical cancer diagnosis. What began as a noble and important plan for an important women’s health issue ended up being a disaster.
The Irish cervical smear scandal – summary
Whatever I write here, I cannot convey the horrible pain and suffering felt by Emma Mhic Mhathúna and Vicky Phelan along with their families and friends. All of it due to an incorrect diagnosis – more factually, the lack of a diagnosis.
Ms. Mhathúna’s settlement with the HSE and Quest Diagnostics did not include a nondisclosure agreement. Thus, we can expect documents that will be released eventually that show what level of incompetence or fraud, if any, that may have contributed to this cervical smear scandal.
But cervical cancer, along with the deaths, falls squarely on Quest Diagnostics and Clinical Pathology Laboratories, irrespective if it is incompetence or unethical behavior. I hope the lawsuits from Ireland continue, and it causes both companies financial harm.
One more thing
- The vaccine protects against 43,000 HPV-related cancers annually in the USA (and even larger numbers worldwide), most of which are not cervical cancer.
- It wrongly assumes that getting an early diagnosis of a potential cancer is somehow comforting. It’s not. It’s more important to prevent cancer than to get a diagnosis – anyone who has had a cancer diagnosis would embrace that without too much thought.
- Finally, based on what we know about the level of incompetence or worse at clinical laboratories that examine these cervical smears, how can any woman rest peacefully if they know their negative result may not be negative?
We have powerful evidence that the HPV vaccine can prevent cervical cancer. Maybe if the vaccine had been available 30 or 40 years ago, the Irish cervical smear scandal would be less tragic. Those women in Ireland who may have received false negative results would rest a tiny bit easier if they thought that they may have been protected against HPV.
- Although I am an American, and the term “Pap test or Pap smear” is more commonly used here, I have chosen to go with “cervical smear” as it is the term used by original stories about Emma Mhic Mhathúna horrendous story.
- Arbyn M, Anttila A, Jordan J, Ronco G, Schenck U, Segnan N, Wiener H, Herbert A, von Karsa L. European Guidelines for Quality Assurance in Cervical Cancer Screening. Second edition–summary document. Ann Oncol. 2010 Mar;21(3):448-58. doi: 10.1093/annonc/mdp471. PubMed PMID: 20176693; PubMed Central PMCID: PMC2826099.
- Van Dyne EA, Henley SJ, Saraiya M, Thomas CC, Markowitz LE, Benard VB. Trends in Human Papillomavirus-Associated Cancers – United States, 1999-2015. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-924. doi: 10.15585/mmwr.mm6733a2. PubMed PMID: 30138307.