"Some women will die.."

At a recent meeting, it was announced by a high level doctor that under the new program "some women will die! It is a screening program, not an absolute and women will die!"

Wouldn't you love to know which women that will be?

[Back in February 2017 the Change.Org petition, Mr Turnbull: Stop May 1st Changes to Pap Smears – Save Women’s, attracted over 70,000 signatures within 2 weeks. Included among the thousands of comments was the following superbly balanced argument that provides clarity to the many issues at stake.]

Why I signed the petition

By Concerned Citizen

As a healthcare professional for over 30 years with a strong focus on women's health and in particular, pap smears, I can categorically say that women should be concerned with the proposed cervical screening changes. Albeit there is absolutely no debate about HPV and that it does cause cancer, the instrumentation used to test for HPV is not robust enough to replace the Pap smear at this time. HPV testing has been available in Australia for many years as an adjunct to the Pap smear. In this forum, HPV testing is safe as you have the cellular indicators as a backup. Without the Pap smear you are reliant on a molecular assay that can be influenced by a number of factors potentially producing a false negative result and sending a woman on a 5 year journey that could result in her developing significant disease.

Change OrgThe proposed renewed cervical screening program has been modeled around the most cost effective option but not necessarily best practice. Some parts of the globe are adopting a co test model which includes both a cellular and molecular assessment. This is the safest and most robust option but is not the best financially and was discarded by the Australian Federal Government. It has been pointed out at numerous meetings that provided you are prepared to pay for healthcare, you can have whatever test you want but in Australia a government funded healthcare system must be affordable. I don't disagree but when epidemiologists calculate the number of dollars spent per lives saved to justify a cheaper, seemingly less robust program you have to wonder where their priorities lie?

At a recent meeting upon receiving relevant questions from the floor, it was announced by a high level Doctor that under the new program 'some women will die! It is a screening program, not an absolute and women will die!' Wouldn't you love to know which women that will be? Not what I would consider appropriate comment when implementing a supposed new and improved program!!

Yes, women do die under today's current program and the Pap smear has received some poor publicity; often ridiculed for being ineffective with an overall increase in cervical cancer by an average of 900 plus new cases per year. Bureaucrats are quick to point out however that the current screening program only has between 40-45% participation leaving 55-60% of the female population never screened or under screened.

Logic dictates that the deaths from cervical cancer and the 900 plus new cases per year are generated from the never screened or under screened population and not the 40-45% of screened women who have enjoyed the most successful and effective screening program in the western world over the last 30 years. Would it not be better to invest money in to educating and attracting the larger population of women who are not screened in to the program?

Australia's multicultural demographic has diversified over the last 10 years with women entering Australia from countries that do not provide healthcare or because of their cultural or religious beliefs would not entertain the notion of a Pap smear. Surely these are the women at most risk and yet are unlikely to have a HPV test any more than they would a Pap smear........so what will change with the new program? Self-collect samples have been advertised as an alternative for these women but the risk of inadequate sampling due to a lack of knowledge, poor collection or anxiety with the procedure is, in my opinion, unlikely to have any meaningful impact in participation and hence we are unlikely to see a decrease in cervical cancer under this program. Invest serious effort in to bringing these women in to the current program; modify the program and offer a co test model of cervical assessment and you will see a significant decrease in cervical cancer.

Every comment that I read from very learned individuals simply quote facts and figures that have been generated by epidemiologists, statisticians and most disconcertingly, the vendors who produce the equipment and assays to test for HPV and who stand to gain the most financially. The focus of the renewed cervical screening program has been primarily on the success of the vaccine over the last ten years followed by predictive statistical modeling to conclude that HPV testing is the best and safest way forward.

The last thirty years of national Pap smear screening data and over seventy years of using Pap smears to diagnose cervical disease have seemingly been ignored in favor of an Australian developed vaccine with little historical data.

There are over 100 different strains of HPV, some low risk of and some high risk of causing cancer. Women are vaccinated against the two most common types of high risk HPV in Australia; laboratories test for the top 14 types of high risk HPV. What about all of the other strains that no one is looking at? As a virus frequently mutates are we not at risk of other strains developing in to high risk types that we don’t vaccinate against or test for? Vaccinators love to use the term ‘herd immunity’ where those that aren’t vaccinated share a protection with those that are by virtue of eliminating the virus. The predictive modeling based on the last few years of HPV vaccine data suggests that the virus will ultimately be eradicated but is based entirely on statistics and a computer program and not real world experience. There are a great many assumptions about how this virus will behave and they are gambling with your health to prove it.

There is also the assumption that all young girls and women will develop antibodies upon vaccination and yet there will be no checks or booster shots to ensure they have developed satisfactory immunity. It has been stated by a high level Doctor that the Australian Government is taking a ‘punt’ on the vaccine and that there is no budget to extend the vaccination program to this level and if pushed would render the entire proposal financially unviable.

With the new program comes the added delay in onset of the screening program from 18 to 25 years of age. I hear all of the time about how we currently over service young women, subjecting them to unnecessary surgical procedures and that delaying the commencement to 25 years will not have any impact and yet in the laboratory we see all too often 16 and 17 year old girls with high grade, precancerous lesions that must be dealt with otherwise they are at risk of invasive disease. It is said that many (not all) of these lesions will regress and disappear without treatment and hence we should sit back and do nothing.

If we are to adhere to this theory, which young women will be the sacrificial lambs that fall outside of the statistical model and develop invasive disease and die before they are 25 years of age because we did nothing? There is an infamous New Zealand case of a doctor (Google ' Dr Herb Green and the unfortunate New Zealand experiment') who believed exactly this and that intervention was superfluous and the disease would disappear of its own accord. Following the deaths of 35 women and numerous others who were subjected to horrendous surgeries it was declared a human experiment without patient consent and an absolute failure. The New Zealand government has in the last month, finally apologized for this atrocity and you would hope will never be repeated and yet here I read about doctors still suggesting that these lesions are over serviced and will regress without treatment.

Alas, working in this field statistics are king and are often forgotten that they represent people - you; and that these ‘over serviced’ lesions and also non HPV related diseases (yes, not all cervical cancers are HPV related and will be completely missed under the new program) are statistically insignificant - statistics that represent you. You will be considered collateral damage to the new screening program - grandmothers, mothers and daughters alike because there is insufficient budget.

In Victoria there is a large scale 5 year study The Compass Trial  being conducted to ensure the proposed program is actually safe, yet the committee responsible for implementing the program is not interested in waiting for this study to conclude. They are going to push ahead....What's the rush? Australia has traditionally been conservative in adopting new technologies and treatments without first appropriate investigation and consideration and yet here we are rushing to be one of the top countries in the world to implement primary HPV testing. Why?

Without any surprise (and thank goodness) it has just been announced that the renewed screening program has been delayed for at least 6 months and will not be implemented in May due to the lack of a new national registry.......run by Telstra Health; a reported $250,000,000 contract awarded to Telstra a few days before the last election and without apparent political debate. Interestingly enough each state has had registries for the last 30 years, any one of which would have been capable of taking on the national role and yet a private company with a poor track record in telecommunications privacy is awarded the contract? Staffing and technology issues have been said to be the major factors with the registry yet there are still no Medicare rebates or guidelines for laboratories to manage the new program. GP's in your communities have little information to advise you on these changes and there is little doubt that the increased referral’s to Colposcopists under the new management recommendations, (85000 per annum currently to 250000 per annum under the new program) is ambitious!

I have sat back and watched and listened for the last two years since this new program was proposed and I cannot remain quiet any longer. The political, academic and financial agendas that seemingly surround this program are astounding. I am not alone in my concerns and many of us see this as nothing more than a national human experiment without patient consent and a significant cost saving exercise on behalf of the federal government (reportedly upwards of $54,000,000 per annum) and those laboratories that can replace highly skilled labor with machines.

If anyone takes the time to read this post I am certain some will endeavor to shoot me down in flames but I am convinced that budgetary constraints and vendors pushing to convince everyone that this is the technology we must all have is largely responsible for this current approach. Not to say that this test should never be introduced but I believe there should be more research and review and an adoption of a co test model until such time that at least the Victorian review has concluded. That way we will have real world data to compare and contrast to and possibly increased confidence that women’s health will not be compromised by moving to this test.

As women of Australia, do yourselves a favor; research this program yourselves and make your own assessment. Do not blindly follow the hype behind the media coverage; sign this petition to highlight your intolerances to being guinea pigs and ensure your health is placed before budget. I am amazed speaking with women in the community that they are convinced they no longer need a Pap smear and that this new test is in some way a blood test! No, you still need the same procedure as before; it’s only what the laboratory does that changes………….do your homework and make your own assessments!

To the Honorable Greg Hunt and Dr Michael Ganon, talk to the laboratories and ask them what they think and what their concerns are, particularly government laboratories that do not have a financial interest in the implementation of this program. I am sure you’ll have a different impression of how safe the proposed screening program is.