Irish Cancer Screening Scandal Erupts, Is Tied to US Lab

Roxanne Nelson, BSN, RN

May 02, 2018

A huge scandal has erupted in Ireland over misread cervical cancer screening results that may have led to the deaths of at least 17 women to date.

A government-funded screening program mistakenly reported negative results to 208 women who were later diagnosed with cervical cancer from 2010 to 2014. Within this group, 17 women have died, although authorities have not yet confirmed the causes of death, American and Irish media reported this week.

At the heart of the trouble is a decision that was made more than 10 years ago to outsource screening samples to be assessed in the United States. At that time, an expert warned against the idea, but the warning was dismissed by Irish officials.

The screening debacle only came to light recently because one Irish victim, Vicky Phelan, 43, who is now terminally ill with advanced cervical cancer, reached a legal settlement of €2.5 million (about $3 million) with the responsible American laboratory company – and then refused to enter into a confidentiality agreement to keep quiet.

Phelan is grateful that she is still alive. "I'm here to tell the tale. And by God, I'm going to take these guys on. I think it's disgraceful what they've been doing to the women of Ireland," she told RTÉ Radio One.

I'm here to tell the tale. And by God, I'm going to take these guys on. Vicky Phelan

The Irish government announced that it is opening an official inquiry and is setting up telephone help lines and emergency testing. It has been reported that 2000 people have called the helpline thus far. Health Service Executive (HSE) stated that last week it established a serious incident management team, which has met twice to further review the cases of women who were given false negative results.

The CervicalCheck Programme, which has been embroiled in the controversy, provides free Pap tests to women aged 25 to 60 years. Any physician or nurse registered with the program can administer the test. CervicalCheck has registered more than 4500 physicians and nurses in various practices and clinics throughout the country. In the wake of the scandal, the clinical director of the CervicalCheck screening program resigned amid allegations that physicians were told not to inform patients of the false negative results.

In a resignation statement, clinical director Gráinne Flannelly, MD, said she was "sorry that recent events caused distress and worry" to women. "I have decided to step aside to allow the program to continue it's important work," she said.

Court Case Reveals Scandal and Cover-ups

The scandal emerged last week when court proceedings from Phelan's lawsuit became public. A mother of two from County Limerick, Phelan filed a lawsuit against Clinical Pathology Laboratories Inc, the Austin, Texas–based company to which Irish tests had been outsourced. The company, which is owned by Australia's Sonic Healthcare, has refused comment on the legal case and screening debacle, according to the Irish Times.

Phelan was told that her test results were negative in 2011, but a second test performed in 2014 revealed cancer. The previous negative smear was then reviewed, in accordance with standing procedure, and was found to be strongly indicative of the presence of cancer.

Her lawyer stated that if she had been diagnosed in 2011, she would have had a 95% chance of a cure. "Instead she is left with what is now an incurable cancer," said attorney Cian O'Carroll in a New York Times account.

Carroll also noted that the government had "pursued a prolonged and aggressive defense, demanding that she prove she had suffered actual loss from the delayed diagnosis, and making her spend three days in court before they settled." Phelan was pressured to accept a confidentiality agreement as part of the settlement, but she refused. The refusal allowed the case to become public.

It was revealed during the case that CervicalCheck's Flannelly had advised a gynecologist in Limerick, Ireland, to file away some audited smear test results rather than inform the women that the test results they had received earlier were wrong.

Flannelly told the physician in a June 2017 email that several women should not be informed about the false negative test results that were discovered in an audit. This correspondence was submitted in the Phelan case. These records became public following Flannelly's acknowledgement that she could not say for certain that all of the women who did not undergo early treatment for cervical cancer because of the false negative reports had been made aware of the situation.

Warnings About US Lab Dismissed a Decade Ago

Much of the controversy surrounds the decision to outsource testing, and to do so through an overseas laboratory. One physician says that he warned against outsourcing screening samples more than a decade ago. According to the Irish Examiner, David Gibbons, MD, then chair of the cytology/histology group within the quality assurance committee of the National Cervical Screening Programme, said that in 2008, he brought his concerns directly to Tony O'Brien, who is the outgoing director general of the HSE.

At that time, O'Brien was CEO of the National Cancer Screening Service. O'Brien defended his decision to outsource as being the only reasonable way of having the screenings assessed in a timely fashion. In 2008, the service "was poor, and I mean really poor," according to O'Brien. Cervical cancer tests were being left in "filing rooms" for up to a year because there was no organized service in Ireland to assess them properly.

As a result, he made the decision to seek help from a company in the United States, because it could offer a service that was not available in Ireland.

"The choice we had in 2008 was not having a proper service, with tests lying around for a year, and possibly doctors examining them on their kitchen table," O'Brien said. "So, do I think the decision [to outsource] was right? Yes, I do."

Gibbons said that he had been involved with the screening program from 2002 to 2006 and that at one stage, a backlog of screenings was outsourced to the US company.

Gibbons pointed to a glaring difference in screening results between those from the US company and those from assessments conducted in Ireland. It showed that the rate of high-grade cervical intraepithelial neoplasia was 1.8/100 in the Irish analysis but only 1.2/100 among those analyzed in the United States.

"One third of high-grade cases we were finding, they were finding one third less," said Gibbons. "That was worrying for us. They were finding too few."

That was worrying for us. They were finding too few. Dr David Gibbons

Notably, in 2008, Gibbons predicted that the outsourcing would become a problem within 10 to 15 years. He added that he and several "very well-qualified scientists" resigned after their concerns were allegedly dismissed.

The decision was made to continue with the outsourcing. It "became a political football, and, as democracy works, the majority pushed it through," Gibbons said.

The chairman of the National Association of General Practitioners, Andrew Jordan, MBBS, told RTÉ Radio One's Morning Ireland show that he and a group of general practitioners were also "unhappy" that screening result were being outsourced.

"We were embracing a system where women were getting an annual smear, where we were telling women they would be okay for 3 to 5 years," he said. "We would obviously prefer smears to be examined and looked at here in Ireland."

Gibbons said that Ireland has an excellent pathology service and some of the best-trained physicians in the world.

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