CHANGES TO CERVICAL SCREENING
Despite the serious reservations that continue to be raised about the NSU’s (National Screening Unit) plan to change the primary cervical screening test from the current liquid-based cytology test to primary HPV (human papillomavirus) screening, the NSU recently announced that it will make the switch to HPV primary screening in 2018. (1) (2)
New Zealand currently has one of the best cervical screening programmes in the world. It was established in 1990 in the wake of the Cartwright Inquiry into the treatment of cervical cancer at National Women’s Hospital. Since then the numbers of women who get cervical cancer and the number of women who die from it have reduced by 60%. (3) MOH statistics reveal that there are now 150 – 160 women who are diagnosed with cervical cancer each year, and about 50 women who die from it.
Many women’s health groups are therefore understandably anxious at the thought of the NSU making changes to New Zealand’s excellent screening programme, and question whether the HPV test will actually be of much benefit to those women who are currently not being regularly screened.
Women who are unscreened and under-screened feature highly in those diagnosed with cervical cancer, and Maori women are disproportionately represented in these statistics. Maori women have a registration rate for cervical cancer twice that of non-Maori women, and a mortality rate about 2.5 times that of non-Maori. (4)
The most efficient and effective way of increasing the rate of regular cervical screening for Maori women and for other under-screened women is to introduce free cervical screening. The AWHC has been actively lobbying for this for some years as we are often contacted by women who do not understand why breast cancer screening is publicly funded, but cervical screening is not.
Need for adequate information
There are in fact several issues that give cause for concern. One of the most important ones is the information the NSU produces for people about its screening programmes. The AWHC and others have protested for some years about the changes needed to the pamphlets and booklets about breast cancer screening. Women need to know about the risks associated with breast cancer screening which include over-diagnosis and over treatment. The NSU has been extremely reluctant to include such information and when it does it is unacceptably brief and downplays the risks...
Use of international statistics
Likewise, when discussing cervical screening the Ministry of Health and the NSU usually begin by announcing that around 275,000 women die from cervical cancer each year and continue to provide international statistics, but do not mention what the actual figures are for women living in New Zealand. Of course, NZ health agencies are not alone in doing this, but that does not make it acceptable to set the scene for discussions about proposed changes to cervical screening by overdramatising the incidence of cervical cancer in this way.
The facts are that over 85% of cervical cancer cases are found in low-resource countries, with the incidence and death rates being the highest in sub-Saharan Africa, Central America, South-Central Asia and Melanesia. (5) Most of these countries do not have organised cervical screening programmes, nor do they have the necessary follow-up diagnostic and treatment services.
While the information about cervical screening, and HPV and cervical cancer that is on the NSU website states that:
“It is estimated that about 80 percent of sexually active women will become infected with HPV at some point in their lives. Most HPV infections have no symptoms, and in nearly all cases (especially in women under 30) the infection will clear on its own in 6-24 months, without the woman even knowing she had it,” (6) the information in the pamphlets on cervical screening does not mention this important fact. (7)
Benefits and risks of the HPV test
Hopefully these resources will all be updated prior to the introduction of primary HPV screening and the important facts emphasised, eg how the body nearly always clears HPV infections without the need for colposcopy or treatment. Women who are identified as having one of the high-risk types of HPV are particularly vulnerable in terms of making informed decisions about the risks and benefits of further investigations.
The March issue of the NSU newsletter features an article about the new consumer-friendly website that the NSU is developing on cervical and breast screening which is due to be rolled out in mid-2016. (8)
The article states that “the website will also be accompanied by a social marketing campaign and new consumer resources to help increase screening rates especially for under-screened and unscreened women. The new website, social media and consumer resources are being designed with the help of advertising agency FCB.”
This is not good news. The experience of women’s health groups is that advertising agencies are often not good at producing health information for consumers, as they do not understand the Code of Consumers’ Rights or the need for informed decision-making. They see their brief as being promotional resources rather than providing evidence-based information on the benefits and risks of cervical and breast cancer screening.
The elephant in the room
The elephant in the room is the influence of big pharma. At the NSU/MOH consultation meeting the AWHC attended in October last year there were more representatives from Roche in the room than consumer representatives.
It was also obvious from a careful read of some of the 87 submissions the NSU received that the drug company was behind some of the statements that when the switch to HPV screening is made New Zealand women must have access to Roche’s FDA-approved HPV test, as other tests were inferior, or not FDA-approved. For example, one submitter, who of course wished to remain anonymous, wrote:
“I strongly recommend that the Cobas® HPV test is considered for use in New Zealand because it is the only clinically validated, FDA-approved and CE-IVD marked assay for first-line, primary screening of cervical cancer.” (9) Another anony-mous submitter even described women’s right to have access to Roche’s test as an equity issue.
It is difficult to know exactly who or what is behind the NSU’s rushed move to adopt an HPV test as the primary cervical screening test. And only time will tell whether it will save money and/or save lives.
Submission on HPV Primary Screening
The National Screening Unit (NSU) requested submissions on the proposed changes to the National Cervical Screening Programme (NCSP).
Auckland Women's Health Council
PO Box 99614, Newmarket, Auckland 1149
3. The modelling work done to date supports the preferred pathway as the one likely to achieve the greatest benefits. However, are there any other options that you believe the NCSP should investigate further?
Given that around 160 women in New Zealand are diagnosed with cervical cancer each year, and about 50 women die of cervical cancer, greater benefits for Maori, Pacific and Asian women are much more likely to be achieved by publicly funding cervical screening. It may even cost less than what is being proposed.
4. What further evidence and/or research should the NCSP consider to gain a comprehensive understanding of the impacts of proposed changes to the screening pathway?
Please provide links or references to any documents the NCSP should consider.
Email any relevant papers that the NCSP should consider to email@example.com.
The consultation document does not provide an accurate picture of the incidence of cervical cancer in NZ, nor the expected benefits of what is being proposed. The AWHC notes that NSU constantly refers to the incidence of cervical cancer in a global context which creates the impression that it is a big problem in New Zealand. It is misleading to provide international statistics on cervical cancer without stating the incidence of cervical cancer in New Zealand and the number of deaths. In response to a question at one of the Auckland consultation meetings, one of the speakers referred to the potential of the new HPV test to bring about a 5% reduction in mortality from cervical cancer in New Zealand. This is an incredibly small benefit – one or two women per year – when considering the financial cost to the NCSP of implementing HPV screening.
The consultation document also does not clearly acknowledge that 80%-90% of women clear HPV infections within a couple of years without the need for any intervention or treatment. This is another important piece of information that people making a submission on the document needed, and that women having cervical screening need to understand when making an informed decision about HPV screening.
When the National Cervical Screening Programme was established, many women who were told they had one of the three stages of cervical intraepithelial neoplasia believed they had cervical cancer. The AWHC fielded many phone calls from very distressed women who did not understand that CIN indicated the presence of abnormal cell changes but this did not mean they had cervical cancer.
The AWHC is therefore concerned that women who are told they have tested positive for hrHPV16 or hrHPV18 may interpret this to mean they are very likely to develop cervical cancer or even that they are already well down the pathway of developing cervical cancer.
The importance of the negative impact on women that information on their positive hrHPV status is likely to have cannot be overstated. Under the current screening pathway women clear HPV infections without being aware they have one. The proposed changes to the cervical screening pathway will result in far more women being identified as being potentially at risk of developing cervical cancer than the current screening pathway does. It is difficult to estimate what effect this will have on women, their commitment to keeping colposcopy appointments, etc.
5. Screening interval
· Please comment on the proposal to routinely screen women every five years.
· Are there any groups of women who may have a higher risk and require a shorter screening interval?
The move to a routine screen every five years may benefit some women but result in others turning up for cervical screening much less often, eg 7 – 10 years. A one-size fits all cervical screening programme that is based on HPV screening may not address the inequities that exist in the current screening programme.
Of course there are groups of women who have a higher risk of developing cervical cancer – those who cannot afford to pay for cervical screening and who do not have regular screening tests, eg Maori and Pacific and Asian women and those living in poverty. These are the women that go on to develop cervical cancer. Unless HPV screening is publicly funded then this is unlikely to change.
6. Age range for screening
· Please comment on the potential change in age range for cervical screening from the current 20–69 years to 25–69 years.
· Should there be an exit test for screening between the ages of 69 and 74 years?
Beginning cervical screening at 25 instead of 20 is a logical change given that the HPV vaccine is protecting an increasing number of women from the most common forms of HPV infections.
However, the NCSP’s educational resources must provide women with information on the very rare forms of aggressive cervical cancer that can occur, especially in young women, who may or may not have had the HPV vaccine and who go on to develop cervical cancer in their early 20s. The media carries many stories of such cases in which the families of the young women who have died subsequently embark on campaigns to lower the age at which cervical screening begins.
More information is needed before an exit screen is introduced for women between the ages of 69 and 74 years. What is the incidence of newly acquired HPV infections in older women? Do older women take longer to clear an HPV infection than much younger women? Does cervical cancer develop more quickly in older women?
7. Referrals to colposcopy (for clinicians)
· If the number of referrals to colposcopy increased temporarily, how would it impact on the capacity and timeliness of colposcopy service delivery?
· What would be the best way to limit any such impact?
· How important is it to your clinical practice to have a cytology result for the women you see at colposcopy?
The current DNA rate is of concern and many DHBs are currently not meeting their colposcopy targets. Increasing the referrals to colposcopy would exacerbate the problem for both the women and the colposcopy services.
8. Screening equity
Please comment on suggested strategies for eliminating inequalities in screening.
The most important strategy for eliminating inequalities in screening is to publicly fund cervical screening and thus bring it into line with other screening programmes in New Zealand, but this strategy is not included in the consultation document.
If the government is serious about improving access to cervical screening for Maori, Pacific and Asian women then it will ensure that these women are able to access free screening.
Other inequities in cervical screening
Women with physical and sensory impairments have to overcome a number of obstacles to screening. These include:
Access to disabled parking close to those doctors who have their practices in shopping or shared parking areas
Getting into those clinics which don’t have ramps for wheelchairs
Some clinics don’t have accessible toilets, or beds that go up and down.
9. Self sampling
· Who should self-sampling be offered to?
· What is the best way for women to test themselves (eg, at home or at a clinic)?
· If a woman tests positive for HPV during self-sampling, she will need either follow-up cytology or referral to colposcopy. What do you think the uptake of follow-up for a positive test would be?
· What issues do you see with self-sampling?
Self sampling should be offered to all women.
The best way is for many women to test themselves may be at home, especially for those for whom transport is an issue. Others may prefer to test themselves at a clinic. Women should have a choice, and self sampling must be free of charge to the women.
Another possibility for the future is for NSU to negotiate with LabTest to play a role in increasing access. The NSU could do the invitation and recall (the population register would be necessary for that), with LabTest providing easy access to HPV testing, and ISPs managing the conversations and follow up with women who then are advised to go for further tests at colposcopy. This would mean there was no need for the General Practices with their wide range of consultation fees to be involved. This would only be for diagnostic purposes in the event of symptoms that need investigation.
One of the issues with self-sampling is that the uptake of follow-up for a positive test is likely to be much lower than the NSU expects, and as already noted significantly increase the DNA rates above what they already are.
10. Invitation and recall to screening
· What should be taken into account when re-designing the NCSP-Register for HPV primary screening?
· What is the most reliable way of systematically inviting women into the programme and recalling them at the appropriate time?
· Whose role should it be to invite and recall women into screening?
The NCSP Register will need to be redesigned to meet the rapidly changing IT environment and be accessible to GPs and other screening providers to enable them to check both the screening history and the HPV vaccine status of their patients. Women will presumably also have access to this information via their patient portals.
The responsibility of inviting and recalling women into the programme should remain with the NSU. All regions must have a cervical screening co-ordinator to oversee and report on the operation of cervical screening in their region.
11. Cervical screening workforce
· Smear takers: What information do you need to confidently engage with your patients if HPV primary screening is introduced?
· Cytopathology workforce: How do we retain gynaecological cytopathology professionals (existing cytopathologists, and anatomical pathology registrars) and maintain their expertise in the long term?
· Cytoscientists and cytotechnicians: What can we do to maintain a gynaecological cytology workforce in the period before HPV primary screening is introduced?
· What should we do to ensure New Zealand has an adequate number of expert gynaecological cytology staff in the long term?
· Histology and molecular biology staff: Does the molecular biology workforce have any additional training requirements?
· How much capacity do histology laboratories have to process a 10–30 percent increase in gynaecological histology specimens?
· Regional coordination, and invitation and recall staff: What is the best way to ensure you are well informed about the changes resulting from HPV primary screening?
Well before HPV screening is introduced all the cervical screening workforce issues must be clearly identified and strategies implemented to ensure that the problems identified in the consultation document do not adversely impact on women’s access to cervical screening, as well as the cervical screening programme’s ability to provide the services.
12. Do you have any other feedback?
The importance of accurate information being provided to women about cervical screening and the proposed benefits and drawbacks of HPV screening cannot be overstated.
The NSU does not have a good track record of providing women with evidence-based information on the risks of screening programmes, and this must change before a new primary screening test is introduced that has the potential to turn many thousands of well women into anxious patients who think they are in imminent danger of developing cervical cancer.
REVIEW OF THE NATIONAL CERVICAL SCREENING PROGRAMME 2011
The need for regular independent reviews of New Zealand’s National Cervical Screening Programme (NCSP) was one of the measures introduced in the wake of the report of Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne region in 2001 – known as the Gisborne Cervical Screening Inquiry. (1)
In January 2011 Jeffrey Tan (Australia), Roberta Howlett (Canada) and Linda Thompson (New Zealand) were appointed to undertake an independent review of the NCSP. The review committee was established by and accountable to Associate Minister of Health, Tariana Turia. The committee’s report was published in August 2011 and contains 39 recommendations.
Despite the National Screening Unit’s attempt to put a positive spin on the review committee’s findings, many of the observations about the current state of affairs within both the National Screening Unit and the NCSP eerily echo evidence and warning statements given in some of the submissions made to the Gisborne Inquiry.
In September 2000 Sandra Coney, director of Women’s Health Action, warned the Gisborne Inquiry in her final submission:
“The history of the NCSP and the Ministry's relationship with it requires that the future involvement of the Ministry of Health be treated with caution” and in arguing for the establishment of a national cancer control agency separate from the Ministry she recommended that the NCSP be located within such an agency. (2)
The “Report of the Parliamentary Review Committee regarding the New Zealand Cervical Screening Programme” (3) contains the following statements:
“The Ministry of Health has restructured many times in this past decade, inevitably affecting the NSU and the NCSP.” (page 8)
“From 2001 and 2011, reports and inquiries on cervical screening highlighted concerns and recommended change in the development, management, autonomy and leadership of the NSU.” (page 43)
“Ministry of Health restructuring over time has confirmed a management structure within the organisation that may have had the effect of compromising clinical leadership.” (page 44)
“Multiple changes within the Ministry of Health carry the risk of loss of institutional knowledge and screening expertise. High staff turnover has translated to lost expertise. The impact on providers and screening participants has been noted with respect to limited or no communication about changes with the loss of continuity and key contacts.” (page 45)
“Externally there is a perception of a general ‘dumbing down’ of both the NSU and NCSP. Feedback has indicated an impression externally of a pervasively disorganised and reactive culture, disconnected relationships with stakeholders and poor co-ordination.” (page 45)
The women’s health groups who attended and closely followed the Gisborne Inquiry were strongly opposed to the prospect of the NCSP remaining within the Ministry of Health due to some of the very problems identified in this report.
After the Gisborne Inquiry, the NZ Cancer Control Trust was established in February 2001. (4) Unfortunately the NCSP remained within the Ministry of Health.
Ethnicity and inequalities
The Parliamentary Review Report noted that increasing participation in the NCSP and reducing disparities in the screening coverage for Maori, Pacific and Asian women are hugely important issues that have yet to be fully appreciated and addressed.
Echoing concerns expressed by women’s health groups over the past few years regarding the establishment of the HPV vaccination programme, the report stated: “there is room for improvement in the organised programme via improved collaboration and integration with the HPV immunisation programme and improved alignment with New Zealand’s cancer control strategy.”
Six of the 39 recommendations concerned improving coverage, participation, equity, access and reducing the burden of disease.
Quality Assurance and Monitoring
A woeful and utterly negligent lack of monitoring is one of the issues that led to the Gisborne Inquiry – prior to 2000 the NCSP had never been monitored despite repeated calls from women’s health groups during the late 1990s for an audit of the programme (5) – and while the review commended progress in the resources that have been expended on quality initiatives, the report stated that “consultation and collaboration between the NSCP and key stakeholders require significant improvement” as “awareness of current NCSP quality activities is very limited.” (page 8)
There were six recommendations on quality assurance and monitoring issues.
Once again echoing the concerns repeatedly raised during the Gisborne Inquiry, the report stated:
“From 2001 to 2011, reports and inquiries on cervical screening highlighted concerns and recommended change in the development, management, autonomy and leadership of the NSU.” (page 43)
“Enhanced leadership capacity – including population health, public health and screening expertise – is urgently required within the NCSP to improve the depth and breadth of expertise and experience within the NSU and NCSP.” (page 9)
Despite the major problems identified during the Gisborne Inquiry regarding clinical leadership within the NCSP, followed by the recommendations from the Office of the Auditor-General Ministry in 2002/03, the report noted “Ministry of Health restructuring over time has confirmed a management structure within the organisation that may had had the effect of compromising clinical leadership," and warned “Clinical experts and advisors must remain as the linchpin in any clinical programme.” (page 44)
There were six recommendations on workforce issues.
The NCSP Register
The register has been a thorny issue since the very beginning of the NCSP and Sandra Coney’s submission to the Gisborne Inquiry contained a detailed account of the repeated attempts women’s health groups made to keep the establishment of New Zealand’s first screening programme focused on cervical screening rather than the register, despite the ongoing intransigence of the Ministry of Health. (5)
The report noted that “complaints to the NCSP have highlighted the need for ongoing public education efforts to inform participants that their screening information is included in the NCSP Register and to advise them of their withdrawal options.” (page 10)
There were six recommendations concerning the NCSP Register.
Organisational & structural issues
The issue of representation for consumer and priority women’s groups was dealt with under this heading. The report stated:
The two remaining NCSP advisory groups must have a stronger role and function to ensure an adequate voice and presence for consumer and women’s groups. These include the NCSP Advisory Group and the Maori Monitoring & Equity Group.”
As a first step in the NSU’s plan to merge Maori, Pacific and other health promoters into one hui, the NSU held a National Leadership & Workforce Development Forum in March 2011. However, the report noted that the NSU still needs to consider whether other priority women’s groups are sufficiently covered by these arrangements.
The review also advised that cervical screening be integrated with other health programmes, and the whanau ora approach must be given priority.
There were four recommendations on organisational and structural issues.
Issues around colposcopy and the HPV vaccine were also addressed in the report.
Finally, the review committee recommended that future reviews be undertaken at 5-yearly intervals instead of every 3 years.
The report ends with a brief section on future directions and refers to the confusion around the respective roles of NCSP and the NSU. The original plan was for the NCSP to provide a service that would reduce the burden of disease from cancer of the cervix. “This would encompass the women who participate, health promotion activities, smear takers and assessment services, laboratories and related staff, treatment services, monitoring agents and evaluation teams.
The NSU is the primary, but not the only, agency responsible for facilitating the organisation of all these activities, but for some, NSU should not have direct control. NCSP is larger than the NSU. Some organisational, accountability and leadership problems are apparently related to a contrary NSU philosophy that the NCSP is merely one of several screening programmes. NSU’s intended role was to facilitate and support NCSP, and it should operate accordingly.
NSU is a major stakeholder regarding successful implementation and maintenance of a cervical screening programme, with a role to facilitate the organisation and cooperation of all the stakeholders and partners.
Yet the main stakeholders have to be the women of New Zealand; without that focus, participation and effectiveness may be reduced.”
The Parliamentary Review Committee’s Report was released with little fanfare. It remains to be seen whether the 39 recommendations will be implemented or whether it will be consigned to history as just another report that highlighted concerns about the NCSP.
Health Promotion Agency
Meanwhile the government is in the process of establishing a Health Promotion Agency to take over the health promotion and social marketing roles of both the Alcohol Advisory Council (ALAC) and Health Sponsorship Council (HSC). (6)
It is not clear if the new agency will also be undertaking all the other work currently done by both councils.
Word has it that for some utterly unfathomable reason the new Health Promotion Agency may also be taking over the NSU’s health promotion and social marketing activities. Whoever thought that this was a good idea obviously has no understanding of the history and role of screening, or the risks involved in removing these important tasks from the NCSP.
Once again the NCSP is about to become the victim of yet another round of governmental restructuring. When will they ever learn?