Vicky Phelan: disapointed, but not surprised.#rtept pic.twitter.com/SyEA5vYXEp
— RTÉ Prime Time (@RTE_PrimeTime) May 1, 2018
Vicky Phelan, her husband Jim and her solicitor Cian O’Carroll (in background)
On Monday morning.
On RTE’s Today with Sean O’Rourke, Vicky Phelan’s solicitor Cian O’Carroll raised concerns about who is auditing the early smear tests pertaining to women in Ireland who were subsequently diagnosed with cervical cancer.
He was speaking after the HSE said 206 women with cervical cancer had been identified as women who should have had an earlier intervention.
Specifically, he said:
“Remember the 206 cases – that ultimately comes from an analysis of cases performed by Med Lab which is the organisation that performed the screening of the smears in the first place.
“So Cervical Check thought it was appropriate to have the clinical audit and lookback performed by the very people who had done such an appalling job at reading the smears in the first place.”
It should be noted Med Lab did not carry out Vicky Phelan’s original screening in 2011 – which returned a false negative.
This was performed by Clinical Pathology Laboratories in Austin Texas – whom Ms Phelan settled her High Court action against for €2.5 million last week.
However.
Med Lab and Clinical Pathology Laboratories are sister companies and have the same parent company, Sonic Healthcare.
Meanwhile…
Last night, on RTE’s Prime Time.
Ms Phelan repeated Mr O’Carroll’s concern about who is carrying out the audit of the smears and the potential conflict of interest.
She raised this concern after the Minister for Health Simon Harris told the Dáil approximately 1,500 women who have been diagnosed with cervical cancer have not had their previous smears audited.
Anyone?
Related: Cover Up And Confidentiality
HIQA, Statutory Enquiries etc.
do either of these involve the Gardai, prosecutions & potentially prison time?
straight question.
I realise this is complicated but to me it’s a case of manslaughter & an attempted cover up. and to my mind that involves prosecutions.
?
Hahaha the gardai. They are part of every good cover up in this state.
Probably not. You’ll probably find out that evidentused in an enquiry can’t be admitted if there’s a subsequent legal move. That’s a ‘backstop ‘ built in for protection of the endowed.
Not at all and if they refuse to cooperate then hiqa have no power to jail them
Criminal case only with real jail time and removal of pensions due to criminal acts
The whole government must go
Watching them debate yesterday I felt sick
All calling the shots and no one except possible Mattie McGrath getting really outraged
There must be no inquiry and immediate suspensions of all who are involved pending criminal charges
This cannot be put to bed
There must be blood and punishment
I really need an article outlining the main points of this case, or failing that a balanced TLDR.
I think something like that would be brilliant. BS usually do a comprehensive job of these things too.
To me they really key points are made by Dr David Gibbons, as featured in Broadsheet on Apr 30.
Three yearly deep tests – fine (our original model)
Annual quicker tests – fine (USA model)
But not the annual test carried out every three years – current crisis as predicted by Dr G.
This is valid. But in 2008 the state’s finances were rubbish. We don’t know why the decision was made to outsource, and if anything was put in place to mitigate these risks. I heard that there was a backlog of 40,000 at the time.
Pretend[1] you are the head of Screening; it is 2008; your budget is slashed – you like to have to make the choice between (a) testing everyone every 3 years with a test that is likely to miss ~30%; or (b) test everyone with a better test, but only do it every 4 years; or (c) reduce the number of people you can test – say 30-55 year olds – every 3 years. which is it going to be?
[1] I don’t know if this is real – but these sorts of choices are made in the HSE – there isn’t unlimited budget, so you need to decide where you put money to get best value.
it was put out to tender long before 2008
anyone asking which bids didn’t get a look in yet?
In 2008 Brian Cowen delayed the introduction of the HPV Vaccine on cost grounds.
He said (essentially) that it was a choice between Cervical Check and the Vaccine.
Brian Cowen wouldn’t have thought twice about cancelling screening on cost grounds if they hadn’t cut the cost. His brother topped the poll in Offally.
If you want to blame someone for this disaster blame the people of Offally (first planted area in Ireland).
https://www.irishtimes.com/news/cowen-accuses-kenny-of-emotional-blackmail-over-vaccine-1.831495
Excuses
Since the bust 200 odd billion of property was disposed by NAMA etc
Instead of being repaid against that debt its gone where?
These excuses are lame
They can borrow to up public sector pay but nothing for the services
this indeed, for me this is a core part of it, I heard his radio interview
the gist I got is that the HSE mis-implemented the screening program to make for a more efficient service from a time & cost perspective
(which is fine & well if we’re talking about a factory that makes cans of baked beans for tesco’s but…)
If I recall correctly they were able to show cost & efficiency savings of 300% BUT what they did to get there was to mash up 2 different & incompatible testing systems
the much derided US system (which I imagine is technically sound just different) relies on a less deep analysis method but coupled with an increased sampling frequency…whereas the local labs did a different deeper analysis method which takes more time but the sample rate were 3 yearly
now if that’s correct, if I did something like this in a datacentre say & some end customer loses data….I’ll lose my job, all hell initially breaks loose but the attitude to it at an upper management level is to allow contractual protections to apply, penalties happen but nobody dies & the outsource partner best effort basis usually survives to fight on another day
but this ain’t computer spindles
Exactly. Even just changing providers requires careful monitoring let alone the first outsourcing. It has incompetence written all over it and even worse, trying to force Vicky Phelan to sign a gagging order was despicable.
that gagging order has me particularly intrigued
might’a mentioned it yesterday
what other scandals and rackets are protected by Non_Disclosures
“the [US lab’s] insurance company required complete confidentiality as a condition of any settlement and this was not acceptable to the plaintiff”
no
If you were doing that in a datacentre you would have to either charge your customer more. or provide a lower level of service.
If your customer demanded the higher service level for the lower cost you’d tell them to get lost.
Smells like a fake news set-up. The subtext is: the state hates all women equally, cares nothing for their health care. Phase two will be the creation of a fake victim who now has cancer and is pregnant but who allegedly won’t receive treatment in the ‘barbaric’ Irish Health system because of the constitutional protection of the unborn.
Repeal the 8th, kill the baby, save the woman.
Am I close?
Ah would you ever grow up…. just a little bit, please….
Sentient Won – That’s a terrible thing to write. What’s wrong with you?
No.
You’re an absolute silly.That’s what you are.
Get some help, yeah?
dontcha be feeding it Mildred
Nutjob is NOT a bad word lads!
I know, Martco. I shouldn’t. I’ll eat chocolate instead and enjoy the sunshine :)
Mental case.
We acknowledge your comment and we refer you to the reply given in the case of Arkell v Pressdram.
Very subtle :)
hah
so this is how we get around the no-swearing-BS now? is it?
well there’s always the rhymes with
and feel free to use what I use in work a lot
2 words; 1 refers to sex
the other to departures
I had to look that up. Funny!
Wait till the bowl screening as in bowl cancer checks are looked at
How many of these could be of interest
False positives missed then told three years later when you go in again that you have cancer
Scary stuff
briefly (and I’m not claiming this to be comprehensive)
Tests sent to USA, pre-cancerous cells missed
At a later date cancer diagnosed (either following next smear 3 years later, or due to other checks)
Vicky Phelan case – she has sued lab in USA for their missing the pre-cancerous cells
All other cases – anyone who was diagnosed with cancer, or diagnosed with pre-cancerous cells, following a routine Cervical Check smear at a later date, has had the earlier smear re-checked.
Two major issues are arising:
The lack of informing women in the all other cases list that an earlier smear may not have been correctly analysed
The fact that only cases of cervical cancer that were diagnosed via the Cervical Check testing regime have been included in the audit. Somehow the number of women who have had cervical cancer that was diagnosed via a route outside the Cervical Check testing regime have not been included in the overall audits. The HSE has a list of all cancer diagnoses, this list was not cross-checked with the Cervical Check list.
There are also questions relating to the suitability of the lab in USA to carry out the testing, and whether or not that was flagged in advance (2008) and ignored.
I don’t understand why people who found out they had cervical cancer outside the Scheme’s results should have been audited: can you explain that to me, please?
Did they have a smear previously that was given an all clear incorrectly?
Just because a cancer may have been diagnosed outside the scheme, doesn’t mean they weren’t tested within the scheme previously
Gotcha. Thank you.
“The lack of informing women in the all other cases list that an earlier smear may not have been correctly analysed”
I personally don’t think that this was a ‘cover-up’. CC didn’t completely bury this, the had approached the women’s doctors and told them that the earlier tests were incorrect, and that these doctors could decide if/when that information should be given to the women. Ms Phelan’s doctor was aware of her misdiagnosis for 14 months before she herself found out. (there was a two between the her being told that she had cancer and her doctor being told that the early tests were incorrect. But I don’t know when within that 2 year gap that CC learned the original results were incorrect)
Saying that – there was an element of cover-up: when a woman had died in the interim – the fact of the earlier incorrect tests were just to be added to the woman’s file – they didn’t explicitly tell the next-of-kin.
Thanks for this.
I’m still a little confused though. Is there a margin of error in these tests? Was there any cases of earlier smears being retested and discovered to be cancerous yet the patient was not informed and assumed they were cancer free?
I don’t know. My understanding is that the audits were triggered (individually) by the second (cancerous) result. As in, if a woman was all-clear 3 years earlier, then she shouldn’t have cancer.
I’m pretty horrified that doctors were prepared to sit on these test results for months while they argued with Cervical Check over who was responsible for passing on the information to the patients. Where on earth was the duty of care here? All the knives seem to be out for the Minister, Cervical Check and the HSE but what about the individual doctors who were prepared to put their patients’ lives at risk by refusing to tell them that there were test results that – at the very least – needed following up.
Not telling the women about the earlier test wasn’t putting their patient’s lives at risk.
In all cases the women had already been diagnosed with cancer and were undergoing treatment. CC contacted their doctors and told then about the incorrect earlier tests and asked them to tell the women if they felt is was appropriate.
“We feel it is inappropriate to contact them at this point to tell them that original smears have now been re-reported as showing different findings. We think this would only heighten their anxiety levels and not confer any advantage to them now in their clinical course, as they have all been managed appropriately,” Mr Hickey wrote.
Mr Hickey was Vicky Phelan’s consultant gynaecologist.
https://www.independent.ie/irish-news/letters-reveal-how-medics-argued-about-disclosing-error-36854996.html
Very informative Cian. Cheers.
Thanks Cian — something close to deliberate disinformation going on with the conflation of failure to inform with failure to treat.
@Cian @Truthful
(per above) do you think that a major misadventure has occurred here due to an effort focused on improving the efficiency & cost of the screening system?
Yes. I believe that.
But (IMO) the media attention is not looking at it this way. They are looking for resignations, they are making it look like HSE knew that women had cancer but didn’t tell them (Indo’s headline “Now 1500 women at risk from test error”… and you see the ‘risk’ isn’t their lives/health – it is that their earlier smears weren’t re-examined. They are looking at the ‘cover-up’ as if CC tried to completely bury the details.
Yes, we need people to question what happened. We need to know if the risks highlighted back in 2008 about the US tests were mitigated in any way.
Thanks Cian, Martco et al for yizzer posts on this thread
@Martco there are a series of issues:
The American lab and the diagnostic methods in use
The failure to inform
The fact that Brian Cowen would have closed the screening service if costs had not fallen
The delay at the time of outsourcing – is this more dangerous than the outsourcing itself or less dangerous
hate to divert ye all
but most of these Doctors are GPs
not Consultant OBGYNs
pretty much all smears taken under the CervicalCheck scheme are through GPs
who may not even be the patient’s own GP
So this is going to get a lot bigger
and a lot more scary
My understanding is that all of these re-tests were preformed after a woman was diagnosed with cancer.
And CC contacted the women’s consultant gynaecologist – who was overseeing their treatment – rather than their GP.
Nope
Well not quite
Say you are considered in the high risk category; had abnormal cell activity but had treatment – usually colposcopy, and are u-45, then you’d usually be called in every 6 to 12 months.
Let me go back there to the treatment, that would be under the care of a Gynie alright, but on your first clear smear after that, you go back to your GP or now Cervical Check since it became available. But since CervicalCheck uses GPs to collect the smears you are still dealing at GP level. If one of these smears shows abnormal activity, another smear is taken and if the result is repeated then you are referred to a Consultant.
The issue in the Dail, the papers and all over Broadsheet is that these audits were only carried out on those patients after they got Cervical Cancer diagnosis, and were already in the hands of a Consultant.
It’s those that got an all clear, from a GP say,
or a GP acting for CervicalCheck and not the girl’s usual GP,
Or may not have heard a word back at all – if there was nothing to report like,
Thinking alls good down there
So are none-the wiser until Cancer does go full blown and only then will their bad tests be discovered on a walk back.
I’d say there are a lot of GPs going through their files at the moment
Let me repeat
it is only when the Cancer has developed is the girl in the care of a Consultant
I’d say there are loads more to come.
Remember this form of cancer is called the Silent Killer; it can brew for years without anyone knowing and the survival rates are not pretty.
This is the cancer that took Jade Goody, it brewed away for years and took less than a year to fully metastasize into terminal. I don’t think she was even 30 when she died.
@frillykeane
Are you trying to write in an unclear and uninformative way? If you are trying to impart information you are failing badly.
Are you trying to tell us that a woman cannot be treated for cancer if no one knows that she has cancer?
she may not know she is ill
she may have got an all clear from a regular smear
and is none the wiser until her next one
which might be in 3 years
or 5 years
But isn’t it possible to go from an all clear test to a positive test 3 years later without any shenanigans?
yes
but far as I can understand (analogy) because they were incorrectly using only 10x binoculars to see what was coming instead of the expensive 60x ones they didn’t see it coming the 3 years prior…today using the 10x binoculars for the current sample schedule sure enough it’s there now on top of you but by then it’s too late
yep
but what’s happened here is that, on the smear that showed the Cancer, they went back to previous smears and discovered the early onset was there all along
so they may have been able to treat handily enough
I’m struggling to understand your question. I can answer for one person:
In May 2011 the patient [Vicky Phelan] 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
CervicalCheck initiated a clinical audit of the patient’s case, as per protocol […], in September 2014 this showed the earlier test results were wrong.
In 2015 a decision was made by HSE, in line with international best practices, 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)
http://health.gov.ie/wp-content/uploads/2018/05/0864_001.pdf
yeah
Cian has it summed up there
the backtrack into previous smears only happens after the now cancer patient is in the care of a Consultant
so say I got an all clear 3 years ago
but my next smear shows something
I am immediately referred to a Consultants Clinic who then orders biopsies etc
and further tests show full stage 2b
That Consultant now is given access to the previous smears to complete my new Patient File case history, and finds that that smear taken 3 years ago actually did present abnormal cells that in the 3 years got on with developing into full Cervical Cancer while I remained oblivious
The Silent Killer
no,
if you had a clear test 3 year ago,
but next smear shows something
you are immediately referred to a Consultants Clinic who then orders biopsies etc and further tests show full stage 2b
That Consultant now is given access to the previous smears to complete my new Patient File case history
, and finds that that smear taken 3 years ago actually did present abnormal cells that in the 3 years got on with developing into full Cervical Cancer while I remained obliviousin parallel with your treatment, Cervical Check will audit your historic records. They would re-send your smears for retest.
Once these are returned, and found to be incorrect, your doctor would be informed – and would decide if you should be told or not.
Ah right
Ta Cian
I’m not sure I follow.
CC are only reassessing old tests once a later test shows cancer (and the previous test was clear). So if a person hasn’t presented with cancer they don’t reassess older tests.
The HSE is unlikely to have every test from the last 3 years (all 800,000+ of them) reassessed.
see what I said to PaddyUlsterMan there Cian
Has this happened elsewhere in the E.U.? I’d love to know if this has occurred in Germany, France or Italy – I’d bet it hasn’t. The Irish Government has a short-termist policy for outsourcing services, services that make a country civilised, to entities where profit is the main objective and we are then all surprised and outraged when standards are dropped to keep the bottom line and director salaries – this was predictable.
A full up in the UK over smear tests – https://www.independent.co.uk/news/health/cervical-cancer-smear-test-women-mixup-all-clear-wrong-review-results-health-a8189821.html
full? ….shoulda been ‘fupp’
@Kolmo
France has no national cancer screening programme.
From a liability perspective, no screening programme is better than one with such failings because when women received clear results, they do not have the checks done elsewhere.
…it depends.
If 80%[1] of Irish women get a test that works 2/3[2] of the time; then you would need more than 54% of French women to privately pay for a test that is correct 100%[3] of the time to get a better outcome.
[1] CervicalCheck have about a 79% uptake
[2] Dr Gibbons suggested that the US was finding 1.2/100 Vs 1.8/100 high-grade samples
[3] no screening is 100% correct
Actually France does have a screening program, they just don’t send out test vouchers. It is by GP referral.
https://www.connexionfrance.com/Archive/Cancer-screening-schemes-in-France
Cervical cancer (cancer du col de l’utérus)
A smear test (frottis vaginal) is offered free to all women from 25 to 65, and is recommended even for those who have been vaccinated against HPV (human papillomavirus, called papillomavirus in French). The first two checks should be a year apart, and then every three years if they produced no abnormal results.
Unlike the screening for breast cancer and bowel cancer, there is no major national campaign to send out smear test vouchers. Your GP or gynaecologist will refer you to a smear test clinic in either a hospital or medical test centre (laboratoire d’analyses médicales). A small cell sample is taken from the uterus and analysed by a specialist (un anatomo-pathologiste).
Also GP visits are free. France has the best universal health care system in the world after all.
Shhh, you’ll wake up Louis LeFronde
(Yes, I know he’s from Canada but it’s exactly his type of thing)
@SOQ Are you telling us that Ireland isn’t the best little country in the world in terms of health care systems?
What are we the best little country in the world at doing again?
we make nice brown bread
and our butter is better than anywhere else
not too shabby at the singing and writing either
and I think we do death and funerals very well
like give our own a proper send off like
Ah now Frilly, we have our strengths and weakness just like everywhere else. A work in progress for sure but I personally wouldn’t swap it.
So they do sadly for Irish with their cards when having to access it your card is no good and you pay up front only to be told on return the Irish government will not reimburse you
So my 2 grand went up the swannie