CervicalCheck controversy

Milkman..

Self-serving press conference as expected

Matt Cooper calling it straight

"Making sure it never happens again"

Must be using the usual scriptwriter

boombang

kaymin wrote: »

You might claim the current operation of CervicalCheck addressed Dr Gibbons issues - if that was the case why would Dr Gibbons and a host of others resign? Why is the US lab settling cases? Why are Dr Gibbon's predictions from 2008 seemingly coming to pass? Suggest reading this article:

https://www.independent.ie/irish-news/health/doctor-predicted-cervical-smear-test-issues-10-years-ago-36858027.html

No-one is claiming the smear test is perfect so lets put that one to bed.

I'm not saying that he's not genuine, but I don't think we should necessarily take it to be the truth either. The article notes that they found difference on a common population size. This implies that it's not the same sample or a random selection from the same population. If Dr Gibbons' sample was from an area of higher incidence, then he would find more disease, all else equal.

I would just like more information from other sources on Dr Gibbons' claims.

We would likely see some false negatives even if everything was done at the Coombe. The question is is there an excess in false negatives and I'm waiting to see evidence of that.

Re the leaflet: wasn't trying to treat you like an idiot; I just wanted to point out that the limitations are flagged at the point of invitation.

I honestly have an open mind about the US labs. What's not been picked up yet is that there could be a regional element of this that points to poor performance at Quest. I know the country is divided up between the labs. The two commercial labs are the biggest. Vicky Phelan, Irene Teap and Emma Mhic Mhathúna are all from the South West. Does that tell us anything? It's a sample of three. I'd like to know about the other 206.

lawred2

probably asked and answered already but does this contracted lab have other clients affected beyond the HSE?

kaymin

knipex wrote: »

Fair play.

I don't know if there was incompetence. I actually don't think there was.

I'm not sure what happened in the lab and I have not seen any reliable source point to a systemic problem with the way the samples were tested.

However I think that the decision not to inform patients that there tests had been given the all clear incorrectly was made with the best of intentions. I dont personally think that it was the correct decision but I can understand that though process.

1. Sharing the info would have had no impact on the patients treatment or outcome.
   
2. It would have had a detrimental impact on the public opinion of the smear test program and probably reduced take up of the program thereby costing lives.
   
3. it would have been another opportunity for certain individuals in media and political circles to make a lot of noise, call for a lot of heads and confuse the situation to a degree that mad 2 (above) orders of magnitude worse.

As I said I don't agree with the decision process but I can understand how it was made.

On the lab issue and the standard of testing I will wait until after the investigation and its findings are published.

And the big outcry over outsourcing of the tests, its a huge red herring. At the time the program was launched there was no capacity in Ireland to perform the quantity of tests that were required. The scheme was piloted in the Midwest and Irish labs couldn't handle the number of samples from that. There was also no lab in Ireland certified to the recognised international standard.

To build the necessary infrastructure woudl have taken years and costs a fortune and then the issue of staffing it. The decision was made to tender the testing to certified laboratories and to just start the program.

Where are you getting your information? There was screening labs in Ireland. If there is no incompetence why is the US lab settling litigation for 2.5m? Best intentions? - the only intention was to limit litigation. Again, sharing the fact that tests were unreliable (over and above normal false results) would encourage patients to seek more reliable tests elsewhere (as opposed to not getting tested at all) - non-disclosure of the extent of false results has most likely cost lives.

Is Dr Gibbons (Quality Assurance chair of the Quality Assurance committee) not a reliable source? Suggest reading this article:

https://www.independent.ie/irish-new...-36858027.html

Mr.Micro

Milkman.. wrote: »

Self-serving press conference as expected

Matt Cooper calling it straight

"Making sure it never happens again"

Must be using the usual scriptwriter

Indeed. Rinse and repeat. When and where have we heard that quotation before. It never gets tired.

boombang

lawred2 wrote: »

probably asked and answered already but does this contracted lab have other clients affected beyond the HSE?

It's a big provider in the US. I think it has been sued for false negatives by US women before. I would caveat that by saying if you are a massive provider of screens you will make mistakes within you millions of screens that you provide, so it's likely that you will be sued.

McMurphy

Milkman.. wrote: »

Self-serving press conference as expected

Matt Cooper calling it straight

"Making sure it never happens again"

Must be using the usual scriptwriter

Anything to be said for another commission?

boombang

kaymin wrote: »

non-disclosure of the extent of false results has most likely cost lives.

You certainly might be right about that, but should we not wait to see evidence of a differential in performance before we rush to judgement?

kaymin

boombang wrote: »

I'm not saying that he's not genuine, but I don't think we should necessarily take it to be the truth either. The article notes that they found difference on a common population size. This implies that it's not the same sample or a random selection from the same population. If Dr Gibbons' sample was from an area of higher incidence, then he would find more disease, all else equal.

Why are you talking about sample selections? There was no sample selections since the entire population of smear samples has been tested. The populations would have been sufficiently large that the difference in results should not have been great - a one-third difference is statistically significant by a very very large margin.

James Brown

Johnny Dogs wrote: »

Anything to be said for another commission?

Looking at the McCabe thing, I don't see any point unless we bring in a foreign team with no ties to either the company or the HSE.

It's so insulting to be given a large bill and a slew of 'recommendations' as we move on, business as usual. We need something with teeth.

iamwhoiam

So the HSE audit the results and must have noticed the higher rate of false negatives from the US lab ?
And yet they carried on using the lab and spent time instead getting legal advice incase women sued . Now that to me is gross negligence and incompetence and still Tony O Brien think HE is the one hard done by . ? What a pompous arse

kaymin

boombang wrote: »

You certainly might be right about that, but should we not wait to see evidence of a differential in performance before we rush to judgement?

The reason I made this point is that Mary Lou is most likely not far wrong if she is claiming the HSE's actions have cost lives. Personally I am happy with what Dr Gibbons has to say on the matter and don't need to await the results of a tribunal in 3 years when it's all forgotten and the HSE has reverted to form.

boombang

kaymin wrote: »

Why are you talking about sample selections? There was no sample selections since the entire population of smear samples has been tested. The populations would have been sufficiently large that the difference in results should not have been great - a one-third difference is statistically significant by a very very large margin.

But were the populations that provided the samples to Dr Gibbons and the Quest the same. Age, region, prior screen history, socio-economic status, smoking rates, all of these things will mean that the disease prevalence won't necessarily be the same in different areas.

Previous media coverage had led me to believe that Dr Gibbons and Quest were working from the same sample, but the article you linked indicates that they're different samples and I'm asking can there be differences in the populations? I think it's a fair question.

boombang

kaymin wrote: »

The reason I made this point is that Mary Lou is most likely not far wrong if she is claiming the HSE's actions have cost lives. Personally I am happy with what Dr Gibbons has to say on the matter and don't need to await the results of a tribunal in 3 years when it's all forgotten and the HSE has reverted to form.

Well, I agree that it would be a farce if we have to wait 3 years for results. Presumably we should be able to get reliable results within a matter of weeks to resolve this to our mutual satisfaction?

kaymin

boombang wrote: »

But were the populations that provided the samples to Dr Gibbons and the Quest the same. Age, region, prior screen history, socio-economic status, smoking rates, all of these things will mean that the disease prevalence won't necessarily be the same in different areas.

Previous media coverage had led me to believe that Dr Gibbons and Quest were working from the same sample, but the article you linked indicates that they're different samples and I'm asking can there be differences in the populations? I think it's a fair question.

The populations would be of sufficient size that the difference in results from both populations should not be statistically significant. A one-third difference is statistically significant by a huge margin.

Mr.H

knipex wrote:

So go before you spread any more misinformation or throw any more insults please go back and actually check the facts.

I haven't thrown insults. I have had insults thrown at me.

Misinformation?

A false positive can only be given as a result of a misdiagnoses

kaymin

boombang wrote: »

Well, I agree that it would be a farce if we have to wait 3 years for results. Presumably we should be able to get reliable results within a matter of weeks to resolve this to our mutual satisfaction?

Yes, we should but considering the HSE couldn't tell which lab did particular tests, I wouldn't hold my breath.

boombang

kaymin wrote: »

The populations would be of sufficient size that the difference in results from both populations should not be statistically significant. A one-third difference is statistically significant by a huge margin.

Can you explain where the samples were from? Genuine question.

boombang

kaymin wrote: »

Yes, we should but considering the HSE couldn't tell which lab did particular tests, I wouldn't hold my breath.

Reporting of stats so far has been very poor undeniably. I'm sure the will have records of all of this in the end (blind faith on my part, maybe).

Mr.H

OK a question for the apologists.

What would be accountability in your eyes? What is the desired outcome that will put things right?

Amirani

kaymin wrote: »

The populations would be of sufficient size that the difference in results from both populations should not be statistically significant. A one-third difference is statistically significant by a huge margin.

Yep a one-third difference is certainly statistically significant, but they may be different populations. As boombang pointed out, if 1 population of smears is all from Dublin and 1 population is all from the South-West, then there may be a reason other than the screening mechanism for differences in results.

Amirani

Mr.H wrote: »

OK a question for the apologists.

What would be accountability in your eyes? What is the desired outcome that will put things right?

The more this has gone on, the more I think mandatory disclosure is necessary. It should be essential that all relevant information is passed to the patient. Relevant obviously needs to be defined, but they should use a broad definition.

There needs to be structural change in the HSE. I'm not sure how easy this is going to be politically, but if ever there was an impetus, this is it. There needs to be a proper board in place for a start. There also needs to be a change in how the HSE interacts with the Minister and the Department of Health - this isn't working. A culture change is needed; memos being circulated about something this significant that are un-signed is completely unacceptable.

As regards this specific saga; a full investigation needs to be done on the key decisions. Who decided to outsource and why? Who decided to withhold information and why? If people are found to have acting unethically in any of these key decisions then they should be removed from their roles.

kaymin

Amirani wrote: »

Yep a one-third difference is certainly statistically significant, but they may be different populations. As boombang pointed out, if 1 population of smears is all from Dublin and 1 population is all from the South-West, then there may be a reason other than the screening mechanism for differences in results.

I didn't realise living in one area versus another was a risk factor for cervical cancer?

boombang

Mr.H wrote: »

OK a question for the apologists.

What would be accountability in your eyes? What is the desired outcome that will put things right?

Good question.

Full report that addresses the information at the tendering point and QA systems during the operation of CervicalCheck.

If the tendering was demonstrably lacking (not just that it was politically unacceptable to somebody with left wing tendancies or was conflicted because they work or had worked in a state run lab), then the responsible staff should be reprimanded in whatever way is possible given that it's almost impossible to sack people in the public service, but that's another argument.

If the firms are found to be in breach of contract, then maybe the contracts can be abandoned or the firms sued by the state. I'm not a lawyer, so somebody else would need to speak to that.

Most importantly, if evidence shows that the US lab has underperformed, then I think the question would be why the did internal QA process not discover this sooner. If the QA controls weren't good enough then I'd want to sack the CervicalCheck staff responsible for that process and the seniors with responsibility in the HSE. A difficulty comes if the performance is worse than the other labs, but still within the requirements of the contract, then there's possibly little legal basis against both supplier and CervicalCheck staff.

That's a start from me.

boombang

kaymin wrote: »

I didn't realise living in one area versus another was a risk factor for cervical cancer?

Physical location clearly isn't a factor in itself, but as it maps onto urban-rural, socio economic and demographic differences it does matter. Only the other day a former Irish screener said to me you could get a batch in from a certain part of the country and you could expect to see more in that than another (#anecdotalevidence).

James Brown

kaymin wrote: »

I didn't realise living in one area versus another was a risk factor for cervical cancer?

It seems socioeconomically anyway. Those from less affluent areas check less, die sooner on average, than those from more affluent backgrounds. There's an article in the Irish Times today on it actually.
https://www.irishtimes.com/news/ireland/irish-news/responses-to-cervical-cancer-controversy-reveal-socioeconomic-divide-1.3490873

Amirani

kaymin wrote: »

I didn't realise living in one area versus another was a risk factor for cervical cancer?

Well it is. The differences between countries can be quite stark:
http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp

https://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/cervical-cancer-statistics

Ireland has higher rates than the UK for example but lower than Belgium. Very likely there's differences within each country too between urban/rural divides etc. Not saying that it's necessarily the reason here but location can be a factor. The populations may be somewhat different, we don't have the information to know either way yet.

kaymin

Amirani wrote: »

Well it is. The differences between countries can be quite stark:
http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp

https://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/cervical-cancer-statistics

Ireland has higher rates than the UK for example but lower than Belgium. Very likely there's differences within each country too between urban/rural divides etc. Not saying that it's necessarily the reason here but location can be a factor. The populations may be somewhat different, we don't have the information to know either way yet.

You are grasping at straws with this line of argument. We're referring to Irish women first of all. Country women move to Dublin and Dublin women move to the country. Can we stick to some medical facts:

Causes and risk factors for cervical cancer include human papillomavirus (HPV) infection, having many sexual partners, smoking, taking birth control pills, and engaging in early sexual contact.

These causes and risk factors apply to women from the country and urban areas equally. There is absolutely no reason why or indication that the HSE would have stratified the population and sent samples from high risk women to Irish labs and low risk women to the US labs

boombang

kaymin wrote: »

There is absolutely no reason why the HSE would have stratified the population and sent samples from high risk women to Irish labs and low risk women to the US labs

Yes, but you know that different regions of the country aren't going to be homogeneous in terms of their risk. Depending on where the large concentration of younger, urban and lower socio economic group women from the poorer parts of Dublin are put then that will make a big difference to the incidence.

We might expect particularly big differences between socio economic groups when screening was introduced first, as wealthier women would have been those that had a good ad-hoc screening history themselves already, so these would have had lower prevalence at the introduction of screening.

Any detail on the population sources for the data Dr Gibbons cited? If he published a research paper on the topic it might explore some of these issues.

kaymin

boombang wrote: »

Yes, but you know that different regions of the country aren't going to be homogeneous in terms of their risk. Depending on where the large concentration of younger, urban and lower socio economic group women from the poorer parts of Dublin are put then that will make a big difference to the incidence.

What evidence do you have to back up that Dublin women are more prone to cervical cancer? Do country towns not have young or less well off? Middle aged women were young once you know. There's so many holes in this line of argument I don't know where to begin!

boombang wrote: »

We might expect particularly big differences between socio economic groups when screening was introduced first, as wealthier women would have been those that had a good ad-hoc screening history themselves already, so these would have had lower prevalence at the introduction of screening.

But this applies equally to both sets of samples sent to Irish labs and US labs.

boombang wrote: »

Any detail on the population sources for the data Dr Gibbons cited? If he published a research paper on the topic it might explore some of these issues.

If Dr Gibbons was aware the samples were stratified in a way that higher risk samples went to Irish labs and lower risk samples went to US labs, then I think he would have factored that into his analysis. These basic claims you're making suggest he's an idiot. If you read the article I linked to there is a raft of experts that resigned because TOB ignored their concerns. GPs also were vociferous in their concerns. But you think they're all misguided and ignored something as basic as lack of homogeneity :rolleyes:

blanch152

kaymin wrote: »

I don't see how it is disingenuous. If it is widely known that smear tests conducted by the US lab are not very accurate then women will get the test done by an Irish lab instead who detect 1/3 more positives. The withholding of the fact that testing conducted by the US lab is inaccurate has, most likely, cost lives.

That is a very big if that is required to show that Mary Lou wasn't disingenuous.

All we know is that the US labs operating under US parameters had 1/3 less postives than Irish labs operating under Irish parameters. However, we have, to date, zero evidence in respect of US labs operating under Irish parameters.

blanch152

kaymin wrote: »

What evidence do you have to back up that Dublin women are more prone to cervical cancer? Do country towns not have young or less well off? Middle aged women were young once you know. There's so many holes in this line of argument I don't know where to begin.

There are different levels of uptake in different parts of the country of the HPV vaccine. That alone creates differences.

One thing that I hope the whole country has learned from this is that the HPV vaccine is so important.

blanch152

Mr.H wrote: »

OK a question for the apologists.

What would be accountability in your eyes? What is the desired outcome that will put things right?

Establish the facts first.

There are people saying that people have unnecessarily died - this is not known.

There are people saying that the US labs underperformed vis-a-vis the Irish labs - this is not known.

kaymin

blanch152 wrote: »

That is a very big if that is required to show that Mary Lou wasn't disingenuous.

All we know is that the US labs operating under US parameters had 1/3 less postives than Irish labs operating under Irish parameters. However, we have, to date, zero evidence in respect of US labs operating under Irish parameters.

Do you know for a fact they operated under Irish parameters? If they did, why did Dr Gibbons et al resign and why did he make his claims of the inappropriateness of the US lab solution to Irish smear tests?

kaymin

blanch152 wrote: »

There are different levels of uptake in different parts of the country of the HPV vaccine. That alone creates differences.

One thing that I hope the whole country has learned from this is that the HPV vaccine is so important.

Creates a difference in what? Is there a difference in the likelihood in a positive result between people that take up the test versus those that don't?

blanch152

kaymin wrote: »

Do you know for a fact they operated under Irish parameters? If they did, why did Dr Gibbons et al resign and why did he make his claims of the inappropriateness of the US lab solution to Irish smear tests?

He resigned in 2008 before they started testing under Irish parameters.

blanch152

kaymin wrote: »

Creates a difference in what? Is there a difference in the likelihood in a positive result between people that take up the test versus those that don't?

If you have high uptake of the HPV vaccine, then you have less incidence of HPV in the community which directly means less cervical cancer which directly means less positive results.

James Brown

blanch152 wrote: »

Establish the facts first.

There are people saying that people have unnecessarily died - this is not known.

There are people saying that the US labs underperformed vis-a-vis the Irish labs - this is not known.

17 women dead - and only two knew of misdiagnoses
https://www.independent.ie/irish-news/health/17-women-dead-and-only-two-knew-of-misdiagnoses-36862040.html

Smear issues are detected more widely by Irish labs
The two laboratories in Ireland that screen cervical smear tests consistently found a higher rate of abnormalities than a US laboratory used by the HSE.
https://www.thetimes.co.uk/article/smear-issues-are-detected-more-widely-by-irish-labs-3mmt6mlb0

The rush to 'nothing to see here' continues for some reason.

kaymin

blanch152 wrote: »

If you have high uptake of the HPV vaccine, then you have less incidence of HPV in the community which directly means less cervical cancer which directly means less positive results.

Right - and what relevance has that for the different lab test results? You are making the assumption that the US lab legitimately had lower positive results yet the head of QA has not made such a claim - the opposite in fact. Why are you making these assumptions when you have no basis for doing so?

kaymin

blanch152 wrote: »

He resigned in 2008 before they started testing under Irish parameters.

Yes, but my questions which you haven't answered, were:

Do you know for a fact they operated under Irish parameters? If they did, why did Dr Gibbons et al resign and why did he make his claims of the inappropriateness of the US lab solution to Irish smear tests?

tretorn

I keep hearing mention of seventeen women who have died.

Did they all die from cervical cancer.

Its looking increasingly now like Governments should not offer free smear testing at all as errors in the results are then leaving the taxpayer liable for millions of euros in damages.

Will the money to pay people affected by the cervicalcheck tests be taken from the general Health budget.

McMurphy

Matt Barrett wrote: »

The rush to 'nothing to see here' continues for some reason.

Ivan Yates made a direct comparison to this scandal and the one with Michael Noonan and Bridget McCole and the Hepatitis C scandal on this evening's show.

boombang

kaymin wrote: »

What evidence do you have to back up that Dublin women are more prone to cervical cancer? Do country towns not have young or less well off? Middle aged women were young once you know. There's so many holes in this line of argument I don't know where to begin!

But this applies equally to both sets of samples sent to Irish labs and US labs.



If Dr Gibbons was aware the samples were stratified in a way that higher risk samples went to Irish labs and lower risk samples went to US labs, then I think he would have factored that into his analysis. These basic claims you're making suggest he's an idiot. If you read the article I linked to there is a raft of experts that resigned because TOB ignored their concerns. GPs also were vociferous in their concerns. But you think they're all misguided and ignored something as basic as lack of homogeneity :rolleyes:

But I don't and can't know any of the relevant data from one radio interview and one newspaper article. I think those are all fair issues to raise. I don't know how Dr Gibbons accounted for them. I think you're being a bit dismissive.

kaymin

boombang wrote: »

But I don't and can't know any of the relevant data from one radio interview and one newspaper article. I think those are all fair issues to raise. I don't know how Dr Gibbons accounted for them. I think you're being a bit dismissive.

In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.

I have not seen anyone, HSE, TOB, Cervicalcheck, Dr Gibbions, Harris, Varadkar etc claim the samples sent to the US labs are lower risk than those sent to Irish labs. Why are you making these claims?

boombang

blanch152 wrote: »

If you have high uptake of the HPV vaccine, then you have less incidence of HPV in the community which directly means less cervical cancer which directly means less positive results.

Vaccinated women haven't hit the screening age yet, do this won't be a cause for difference at the moment at least.

boombang

kaymin wrote: »

In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.

I have not seen anyone, HSE, TOB, Cervicalcheck claim the samples sent to the US labs are lower risk than those sent to Irish labs. Why are you making these claims?

I'm not making that claim, I'm just asking can differences in the source population account for the differences and how different are the populations that gave rise to those numbers?

Amirani

kaymin wrote: »

Right - and what relevance has that for the different lab test results? You are making the assumption that the US lab legitimately had lower positive results yet the head of QA has not made such a claim - the opposite in fact. Why are you making these assumptions when you have no basis for doing so?

No, you're making the assumption that the populations being tested by different labs are exactly the same. This is not something that we know, the information isn't available to us. They may or may not be the same, we don't know.

We're awaiting the publication of results from different labs.

kaymin

boombang wrote: »

I'm not making that claim, I'm just asking can differences in the source population account for the differences and how different are the populations that gave rise to those numbers?

If this was a relevant point it would be apparent already in the various media reports and expert commentary. So, no.

kaymin

Amirani wrote: »

No, you're making the assumption that the populations being tested by different labs are exactly the same. This is not something that we know, the information isn't available to us. They may or may not be the same, we don't know.

The risk factors apply equally to women up and down the country. There is no assumption being made, it's apparent to anyone with an ounce of commonsense. Do you ever wonder why this is never brought up by any of the experts / media / HSE / Cervicalcheck / Head of QA

The HSE has already disclosed the results from the different labs:

In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.

iamwhoiam

kaymin wrote: »

The risk factors apply equally to women up and down the country. There is no assumption being made, it's apparent to anyone with an ounce of commonsense. Do you ever wonder why this is never brought up by any of the experts / media / HSE / Cervicalcheck / Head of QA

The HSE has already disclosed the results from the different labs:

In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.

That is shocking that that didn't alert anyone ? They continued using Quest and so putting a certain percentage of womens lives at risk ?