Massive failure in cervical cancer screening prompts Ireland to overhaul testing

In the wake of a massive cancer screening failure, Ireland is set to start testing women for cervical cancer with a test for human papillomavirus (HPV) — something a Canadian study recently recommended.

To date, 221 Irish women have been diagnosed with cervical cancer after receiving false negatives on their Pap tests; 18 of them have died. 

The study, released last week, found the HPV test is significantly more effective than a Pap test in identifying precancerous cells. It could have done a better job detecting the cancer early, according to experts — perhaps long before the women became ill. 

The flaws in Ireland's free national screening service, CervicalCheck, emerged in April when Vicky Phelan, 43, sued the Irish Health Service Executive (HSE) and the U.S. laboratory that misread the results of her test in 2011. Even after the false negative was discovered and relayed to her doctor, she wasn't informed for another 15 months. She is now terminally ill.

Her case triggered a national scandal. Prime Minister Leo Varadkar announced an inquiry, along with compensation and health supports for those affected. The head of the HSE stepped down. And CervicalCheck has set up a helpline and a team to audit the tests of other women who've been diagnosed with cervical cancer. It's also changing its screening protocol.

"Later this year, we are moving to a new type of smear test, where we will also test for the presence of HPV virus," CervicalCheck said on its website. "The testing for HPV will offer an additional level of accuracy and reassurance."

HPV is a sexually transmitted infection that is associated with the vast majority of cervical cancers.

In fact, the Canadian clinical trial, published last week in the Journal of the American Medical Association, recommended replacing the Pap test with the HPV test rather than using them in tandem, as CervicalCheck plans to do.

Audit of tests showed 'different result'

Since details of Phelan's case came to light, the agency expressed its "deepest apologies" for what it characterized as "a very serious breakdown in communicating" and has been providing updates on its response. 

CervicalCheck says approximately 3,000 women in Ireland have been diagnosed with cervical cancer since 2008. About half of those cases were referred to the agency, which was then able to review the women's screening histories — part of routine "quality control" undertaken in 2014.

It was in the course of this audit of 1,482 tests CervicalCheck discovered that in the cases of 221 women, "on look-back, the screening test could have provided a different result or a warning of increased risk or evidence of developing cancer."

The false negatives were never communicated to the majority of women affected.

In May, CervicalCheck announced that 18 of those women have since died, although the causes of death have not been confirmed. 

Some of the others have filed lawsuits.

Phelan settled her case in April for 2.5 million euros.

Emma Mhic Mhathuna, a 37-year-old mother of five, also sued the HSE and the U.S. lab that misread her slides, and recently reached a settlement of 7.5 million euros.

Mhathuna was given the all-clear for cervical cancer in 2010, 2011 and 2013, but developed the cancer anyway and is now terminal, the Irish Times reported. The cancer has spread to both lungs and to her spine. On Thursday, Mhathuna announced on Facebook that the cancer has now spread to her brain.

System 'let women down'

The prime minister said the system "has let women down." He vowed to get to the bottom of what happened.

"The fundamental rule of medicine, of public health care, should always be to put the patient first and never do harm," Varadkar said in May. "Many women in Ireland are frightened today, many families are traumatized and people have been let down because this principle was not followed."

Questions remain about who knew what, and when — and that's what Dr. Gabriel Scally, of the Royal Society of Medicine in the U.K., will look into as part of an independent inquiry. His initial findings were published June 12 and his recommendations are already being implemented.

The country's Health Information and Quality Authority, an independent agency of the health ministry, has urged the government to ditch the Pap test altogether and adopt the HPV test as the primary screening method for cervical cancer.

"Compared with the current strategy, primary HPV screening is a better test which will allow all women participating in screening to be aware of their current HPV status and those at high risk of cervical cancer to be picked up earlier," deputy CEO Dr. Mairin Ryan said in a statement to CBC News.

"Once primary HPV screening is implemented, women can be assured that the risk of false negatives will be substantially reduced."

The Irish Cancer Society agrees, as does the pathology faculty at the Royal College of Physicians of Ireland, which is establishing an expert advisory group on cervical screening.

In Canada, the Society of Obstetricians and Gynaecologists also supports HPV testing. "Our HPV guideline is still in development, however we are supportive of HPV molecular testing becoming integrated into provincial cervical cancer screening programs," CEO Dr. Jennifer Blake told CBC News via email.

There is no plan to start using it in Canada as yet.