An American Lab Test Abroad
In 2014, complaining of bleeding between menstrual periods and after intercourse, Vicky Phelan went to her gynecologist in advance of her scheduled check-up and was informed that she had cervical cancer: examinations detected a golf ball-sized primary tumor as well as multiple lymph node metastases. Phelan, a mother of two in her early forties who worked at a literacy development center at a university in Waterford, was otherwise healthy: she did not smoke, drank only in moderation, and had participated in marathons. The grueling course of treatment recommended by her doctor included a hysterectomy as well as radiation and chemotherapy, at the end of which it appeared that the cancer had gone into remission.
But less than three years later, suffering from persistent lower back pain, Phelan returned to the doctor and learned, as she had feared, that tumors had returned––only now the prognosis was much worse than the first time. In an interview with RTÉ, Ireland’s national broadcasting service, Phelan describes having to wait until her young daughter was in bed before she could break the news to her mother: the doctor had informed her that the cancer was terminal.
In the course of her second round of treatment, Phelan’s doctor would deliver another bombshell: a much earlier screening for cervical cancer that had given her the all-clear had been wrong, he now informed her––and the government body in charge of administering the exam, the Health Service Executive, had long known, but hadn’t informed her. The incorrect test was from 2011, years before Phelan’s first diagnosis. Her doctor now predicted that she had only months to live.
The April 2018 verdict in the court case against the lab that incorrectly processed Phelan’s smear test ended in a €2.5 million settlement in Phelan’s favor and––thanks to her refusal to sign a non-disclosure agreement, as earlier settlement proposals had stipulated––eventually exploded in one of the biggest scandals in recent Irish history: the revelation that a 2014 audit had found that 221 Irish women had received false negatives from improperly processed cervical cancer screenings, that the HSE had failed to communicate this to most of the affected women, and—most damningly—that it continued its relationships with the labs that had produced the faulty results.
What had begun as a stop-gap measure quickly became a fixture of the HSE’s cervical cancer screening program.
If detected in the early stages, the five-year survival rate for cervical cancer is 92 percent, a figure that drops off precipitously once the tumors begin to spread; by the time Phelan’s lawsuit made the scandal known, many of the affected women had seen their cancer develop far beyond the stage it was at when they submitted to screenings that erroneously gave them the all-clear. As of the time of writing, eighteen of the women identified in the audit have died.
The story consumed the Irish media for months after the verdict’s announcement, with each passing week seeming to bring a new twist in the saga, whether it be another HSE official’s resignation, a development in the multiple legal actions the situation has spawned, or the news that the 221 known cases may be a gross underestimate of the total scope of the crisis. (That figure represents only the number of false negatives found in a sample of patients later diagnosed with cervical cancer, meaning that more screening failures might have occurred both outside the sample of diagnosed patients and among sampled women who have never received a diagnosis.) The announcement that a team of British cytologists would be reviewing the screenings of all Irish women who had been diagnosed with cervical cancer since 2008, an attempt to assuage the public’s fears, was as much as anything else an inadvertent testament to the fact that Irish citizens’ confidence in their own health system has reached absolute zero.
It might be comforting to paint the decisions leading up to the spate of faulty exams as a series of disastrous and deeply regrettable mistakes; in fact, they were a deliberately prosecuted course of action pursued despite repeated warnings from experts and advocates. This course of action, and its underlying logic of profit-driven, privatized health care, has ramifications far beyond the Irish state.
The Irish government provides women between the ages of twenty-five and sixty with free pap smears via a cancer screening program known as CervicalCheck. Begun as a smaller pilot in 2000, CervicalCheck was launched on the national level in 2008. A major issue plaguing the Irish cancer screening program was its difficulty promptly handling the volume of exams it had to go through: over a million women fell within the program’s age range, and the small number of Irish labs approved to process CervicalCheck screenings meant that wait times for results quickly ballooned. Rather than focusing on developing internal capacity, however, the HSE decided to look outward for a solution. When ad-hoc outsourcing to labs abroad in an attempt to assuage the backlog resulted in a rapid turnaround, the government body decided in 2008 to award two longer-term contracts for test processing to American companies, Quest Diagnostics and CPL Labs, a sister company of MedLab Pathology. What had begun as a stop-gap measure quickly became a fixture of the HSE’s cervical cancer screening program.
Alarm bells were rung early on by scientists worried that outsourcing would lead to a medical systems mismatch with disastrous consequences. Ireland and the United States conduct cervical cancer screenings along different timelines, engendering differences in how labs in the respective countries analyze their results. In the United States, smear tests are recommended every year, whereas in Ireland they are recommended once every three to five years, depending on the age of the woman. As a result, the Irish labs adopted a “deep screen” method of looking at the smears, whereas American labs use a shallower level of analysis that is supposed to be offset by the frequency of the exams. In addition to this, there are methodological differences between the two countries’ screening systems, chiefly that Irish labs rescreened every test that came back negative, whereas U.S. labs only rescreened a fifth of these negative results. If Irish smear tests were sent to U.S. labs for processing, the fear was, they would be treated like American tests––which, given the relative infrequency of Ireland’s state cervical cancer screenings, could very easily have disastrous consequences.
This course of action, and its underlying logic of profit-driven, privatized health care, has ramifications far beyond the Irish state.
These concerns were raised even before the American labs had been awarded the long-term contracts. In 2007––when test outsourcing was still a temporary solution––staff at Cork University Hospital identified two cancer cases that Quest had failed to detect, resulting in a number of tests being sent back to the lab to be redone, the Irish Medical Times reported. The article seems to have gone widely unheeded at the time of its publication. Resistance to the move overseas also came from those working on the government’s public health initiatives. Dr. David Gibbons, who chaired the cytology and histology group of the National Cervical Screening Programme, expressed doubts about a move to American processing centers in 2008. “Our scientists were screening twenty-five to thirty cases a day; American scientists were screening eighty to a hundred,” he explained in an interview with RTÉ––but the speed that appealed to the chronically backlogged HSE was actually part of the problem. Giving the Irish smears the “quick screen” treatment would result in a spike of false negatives, Gibbons argued, possibly even as many as 1,000 a year, according to his preliminary calculations. He pointed to data showing that the rate of pre-cancerous cell detection was one-third lower in the U.S. labs than in Irish labs. After attempts to raise these concerns with Tony O’Brien (then CEO of the National Cancer Screening Service) were met with opposition, Gibbons and a group of fellow scientists resigned in protest. This gesture, too, went unheeded; the outsourcing plan rolled ahead.
The predictions of Gibbons and others were confirmed when CervicalCheck conducted an internal audit of its cases in 2014: a routine quality control assessment looked at roughly half of the 3,000 cervical cancer diagnoses in Ireland since 2008 and found that a number of women had received false negatives from CervicalCheck exams. No medical test is foolproof, and no lab technician is impervious to error; nevertheless, this number of false negatives was markedly higher than the generally accepted rate of 5 to 10 percent in the case of pap smears. At this point, a critical signal failure occurred. Rather than relaying the information uncovered by the audit to the patients affected, the government elected to restrict the information to “educational and training purposes only.” Irish pap smears, meanwhile, continued to be sent abroad for analysis after the audit.
Beginning in 2016, after an apparent change of heart, CervicalCheck began forwarding the audit’s findings to the physicians of the women in question––but made no move to contact patients directly. The Vicky Phelan trial made public a chain of correspondence between Kevin Hickey, Phelan’s doctor, and Gráinne Flannelly, then clinical director of CervicalCheck (her resignation came directly after the publication of these messages). In the messages, Flannelly argues quite simply that not all women should be informed of the results. The conversation then devolved into an argument about whose job it was to tell patients about CervicalCheck’s failures in those cases where they “should” be told. The two clinicians’ buck-passing fight dragged on until Hickey decided to inform Phelan of her audit results in September 2017. In the case of at least 162 women, however, nothing about the audit was ever communicated. Had Phelan not undertaken her lawsuit against CPL Labs, it is unclear whether this information would ever have been disclosed.
Mostly missing from the media firestorm surrounding the cervical cancer scandal has been a consideration of how the contracts awarded to American medical labs illuminate the degree to which the HSE was willing to cut costs at the expense of Irish citizens, as well as how the use of U.S. labs fit into the broader trend of “creeping privatization” in Irish health care more broadly. Even a cursory look at Quest Diagnostics’ litigation history is enough to immediately raise red flags. A whistleblower lawsuit settled in 2009 alleged that between 2000 and 2006, one of the company’s subsidiaries knowingly manufactured and marketed faulty tests for parathyroid hormone levels, thereby defrauding the federal government by engendering false Medicare claims. The tests, used primarily on dialysis patients, had a tendency to report high results; to combat the perceived elevated PTH levels, doctors prescribed vitamin D injections, which can cause blood vessel calcification when used in excess, and even parathyroid gland removal surgery, forcing patients to undergo needless, painful medical interventions. The lawsuit’s $302 million settlement is the largest sum a medical testing company has ever had to pay in relation to a faulty product. Around the same time, Quest settled another lawsuit alleging that it deliberately submitted duplicate reimbursement claims for thousands of blood work procedures over a ten-year period, again defrauding the federal government. In a third case, the lab paid a $6 million settlement over allegations that its subsidiaries had offered kickbacks to doctors who used their tests and waived the copays of patients who opted for their services; the suit also alleged that the company had encouraged physicians to order unnecessary testing.
The use of U.S. labs fit into the broader trend of “creeping privatization” in Irish health care more broadly.
These recent cases belong to a much longer history of fraud and malfeasance––and patient advocacy groups raised this issue shortly after the tendering process that landed Quest its original contract in 2008, presenting state officials with details of almost a decade of the company’s legal entanglements. But in spite of the repeated allegations that Quest had cheated government health care programs in the United States, the HSE did not change course. Questioned in 2008 about whether or not he was aware of the company’s pattern of fraud accusations before Quest was selected for CervicalCheck, Tony O’Brien––the same man who dismissed concerns raised by Gibbons and his colleagues about the Ireland-U.S. screening system mismatch––admitted that he was. The analysis outsourcing plan should go ahead anyway, he argued, because the contracts that had been drawn up ensured that the Irish government wouldn’t be bilked out of any money. (The settlements and legal proceedings related to the cervical cancer scandal, incidentally, are expected to cost the state hundreds of millions of euros––to speak only of their financial costs.)
Perhaps it should come as no surprise that the price requested in Quest’s tender happened to be significantly lower than its competitors for the contract––a third lower than the cheapest Irish lab, according to Mary Harney, Minister for Health and Children from 2004 until 2011. Even more damningly, recently released documents from 2012 (when a new contract bidding process again selected Quest) found that price seemed to be the primary or even sole factor in the choice––“lowest price” was ticked under “award criteria,” with no information about other factors.
The HSE also put the bottom line before patients’ wellbeing in its dealings with CPL, the lab that failed to detect squamous cell carcinoma in Vicky Phelan’s 2011 screening (though that company has not been accused of the same litany of legally dubious actions). CPL offers a tiered system of cervical cancer screening options: the cheaper, lower tier has a speedier turnaround but is also known to be less accurate, while the higher tier, which takes longer and is more expensive, includes screenings for the human papillomavirus (HPV), a major cause of cervical cancer. According to a recent Canadian study, HPV tests detect almost 60 percent more precancers than regular screenings. But with its emphasis on getting quick results on a budget, the Irish government made a grave sacrifice when it came to quality.
Another early concern about outsourcing was that slackening the demand for skilled technicians capable of interpreting the CervicalCheck results in Ireland would have a broad, deleterious effect on the capacities of the country’s public sector medical institutions. Moving tests abroad would result in Irish labs losing the cytology expertise required to handle smear tests, thereby entrenching the reliance on overseas labs. The Medical Laboratory Scientists Association, a union of scientists working in public labs, opposed the outsourcing proposal from the first. Terry Casey, the union’s general secretary, pointed to a number of obstacles facing public labs in their attempts to outbid Quest and CPL, including inadequate funding and the fact that the tendering process was slated to end before most of the public labs were scheduled to receive the prerequisite accreditations. In the push for privatization that characterized Harney’s time as Minister for Health and Children, the HSE seemed to have stacked the deck against Ireland’s own medical institutions, and only in the years to come will the full effect of these policies on the country’s cytology capabilities become clear.
Ireland’s health care sector is not alone in moving away from the public model: the years since the collapse of the Celtic Tiger have been characterized by privatization across areas as diverse as education, water, and social housing “in a creeping fashion and often by stealth, drift and incrementalism,” write Mary Murphy and Fiona Dukelow, authors of The Irish Welfare State in the Twenty-First Century. Over the past two decades nursing homes for the elderly have gone from majority-public to mostly for-profit, with a concomitant downturn in quality as profit margins take precedence over patients’ wellbeing. The series of decisions that led to the outsourcing of the CervicalCheck processing to the highly privatized United States, then, was a deliberate move in the grim neoliberal calculus that goes on daily in health systems and other sectors, not just in Ireland, but across the globe.
In May of last year, Trump signed a “right-to-try” law, which aims to allow terminally ill patients to access drugs which haven’t been approved by the FDA. Cloaked in the wholesome, broadly appealing language of patients’ rights and advocacy on behalf of the dying, several commentators have pointed out that such a move sets a dangerous precedent for eroding the FDA’s regulatory powers, casting it as an obstacle to quality treatment rather than its insurer. This lines up with the administration’s contempt for the very concept of regulation, as well as with the way that anti-FDA gadflies in Trump’s orbit have variously promoted such measures as eliminating Phase III clinical trials and removing the assessment of drug efficacy from the agency’s remit. At a time when even the most modest barriers against a pharmaceutical Wild West are coming under attack in the United States, Ireland’s unfolding health care disaster provides a grim vision of what happens when privatization is combined with a lack of transparency. For Ireland itself, the scandal is a lesson in so much that is wrong with the Irish health care system and the way it regards its patients––if the country will heed it.