NZ Ministry of Health to consult on changes to cervical screening test!

September 30, 2015

 

We found this on the Beehive website yesterday:

 

Consultation on changing cervical screening test

 

Health Minister Jonathan Coleman says the Ministry of Health is seeking views from the sector and the public on changing the cervical cancer screening test.

 

“New Zealand has one of the most successful cervical screening programmes in the world,” says Dr Coleman.

 

“Over 73 per cent of women aged between 20 and 69 have regular smear tests. Around 160 New Zealand women develop cervical cancer each year.

 

“There is always scope to further improve screening. The Ministry is seeking views from the public and the health sector on making the HPV test the first test for women being screened for cervical cancer.”

 

Currently cervical screening involves analysing cells from the cervix to detect changes that could indicate an increased risk of developing cervical cancer.

 

The HPV test detects over 90 per cent of the human papillomavirus which is the major cause of cervical cancers. HPV screening is a different way of testing the cell sample.

 

What happens at a woman’s cervical smear appointment would not change. As HPV is a more effective test the average of 18 screening visits in a woman's lifetime would drop to ten with screening every five years instead of every three years.

 

“The HPV test is a better way to identify women at higher risk of developing cervical cancer than the current test. The proposed changes would make the screening programme even more effective,” says Dr Coleman.

 

“HPV is accepted internationally as a better primary test, and a number of countries are implementing HPV screening including Australia, the UK and the Netherlands.

 

”The protection offered by the HPV vaccination programme and the HPV test would ensure screening can provide a greater level of reassurance of finding cancer early, resulting in better health outcomes for New Zealand women.”

 

If the HPV test is adopted, the Ministry of Health will work with the sector to ensure a smooth transition and manage any potential workforce changes. Cytology will continue to have an important place in cervical screening.

 

The consultation period on the proposed changes to the cervical cancer screening test begins today and closes on 23 October 2015.

 

We then emailed them a link to an article in Business Wire about how pap smear cytopathologists should review the DNA sequencing for HPV in a similar way that cardiologists use EKG. nternationally recognized American pathologist Sin Hang Lee, MD, in a recent keynote address told conference attendees that doing so would result in a revolutionary improvement in increased diagnostic accuracy for physicians and patients.”

 

Dr. Lee told attendees that each positive human papillomavirus (HPV) test report should be accompanied by a signature DNA sequence fully matched with a GenBank standard sequence as the physical evidence, “like the EKG in a cardiologist’s report,” to confirm the genotype of the virus detected. DNA sequencing is the gold standard for HPV genotyping.

 

Only persistent infection evidenced by finding the same HPV genotype in repeated cervical samples is associated with cancer risk. However, said Dr. Lee, an extremely sensitive HPV test is needed to reduce the chance of false negative results if an HPV test is relied upon for cervical cancer detection. The PowerPoint slides of Dr. Lee’s presentation are posted for public viewing on the website of Milford Molecular Diagnostics: http://dnalymetest.com/images/Cytopath_Keynote_2015_-_SHLee.pdf .

 

Dr. Lee also advised that when a Pap smear shows a high-grade squamous intraepithelial lesion (HSIL), the report must contain a copy of the microphotograph image of the premalignant cells as physical evidence based on which a cytopathologist’s diagnosis is made because Pap smear cytology classification is highly subjective and not always reproducible.

 

Cytopathology is a profession created to implement Pap smear as a screening tool for cervical cancer prevention with great success. But DNA testing is found to be much more sensitive in detecting HPV infection, a necessary factor in the pathologic process which may lead to cervical cancer development in a very small fraction of HPV-infected patients. Most HPV infections are cleared spontaneously within one year. Referring all one-time HPV-positive women without Pap smear cytology to colposcopic biopsy is causing too many unnecessary, traumatic and harmful procedures on women at great cost to society, said Dr. Lee.

 

“Pap smear cytology is more accurate in distinguishing a premalignant or malignant process from other benign conditions and cannot be replaced by HPV tests as suggested by some experts working as consultants to the HPV industry,” said Dr. Lee.

 

 

Just when we think we are getting somewhere, the Centre for Adverse Reactions Monitoring put out a release dated 10 September 2015, that we only came across yesterday. Essentially, it ruled out any safety concerns regarding HPV vaccinations and autoimmune conditions! The full Minutes can be read HERE.

 

Below is the relevant text regarding HPV, as other things were also discussed:

 

3.2.3 Gardasil and autoimmune diseases

 

Background

 

Gardasil is a recombinant vaccine against human papilloma virus (HPV) types 6, 11, 16 and 18. It is prepared from highly purified virus-like particles (VLPs) of the major capsid protein of the four strains. The vaccine is produced in recombinant yeast: Saccharomyces cerevisiae and the VLPs self-assemble and are adsorbed onto amorphous aluminium hydroxyphosphate sulphate.

 

Gardasil is indicated in females aged nine to 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts and infection caused by HPV types 6, 11, 16 and 18. In males nine to 26 years of age it is indicated for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6, 11, 16 and 18.

 

Cervarix is a similar vaccine against HPV types 16 and 18.

 

Both vaccines are approved in New Zealand but only Gardasil is funded. The immunisation schedule is 0, 2 and 6 months (ie, second dose is given 2 months after the first dose and the third dose is given 6 months after the first dose).

 

Some HPV infections are sexually transmitted (including 6, 11, 16 and 18), consequently HPV vaccines have attracted concern from people who are anti-vaccine and those who consider that this vaccine promotes promiscuity.

 

The purpose of this paper was to provide a summary of published observational studies investigating the possible association between HPV vaccine and autoimmune conditions.

 

Discussion

 

Members were reminded of the Committee's terms of reference which is to provide expert advice to the Minister of Health on the safety of approved medicines. The Committee noted that this is a political and highly emotive issue. It is important that the discussion is balanced and the general public informed accordingly.

Gardasil was shown to have very high efficacy in clinical trials. Post-market data from Australia indicate that the incidence of cervical abnormalities being detected through smear testing is lower among vaccinated subjects compared with non-vaccinated subjects. The conditions that this vaccine prevents can be serious, in particular cervical and throat cancer. The Committee considered that the threshold for safety concerns with vaccines is lower than with medicines. This is because vaccines are administered to healthy people.

 

The Committee discussed the timing of HPV vaccination which in the New Zealand Immunisation Schedule starts in females aged 12 years. One of the reasons why HPV vaccination starts at this age is to ensure that vaccination covers the peak risk period. However, the Committee noted that autoimmune conditions have a higher incidence during puberty and adolescence than in early childhood.

 

The Committee noted that autoimmune conditions include a wide range of conditions that have varying mechanisms of occurring. This was a limitation of some of the observational studies which grouped different conditions together. The difficulty in determining the onset time of these conditions also makes it difficult to perform these studies. However the additional sensitivity analyses and case investigation in these studies supported a lack of association.

 

The Committee were unanimous that based on the evidence presented, there is no safety concern relating to the development of autoimmune conditions after HPV vaccination. Ongoing surveillance and reporting of adverse reactions to the Centre for Adverse Reactions Monitoring (CARM) is occurring and it is important that this continues.

 

Additional information presented and discussed:

 

The Coroner's draft report on the death of an 18 year old female was made available to Medsafe a few days before this meeting. A copy of this draft report was circulated to Committee members before the meeting and was presented to the Committee at the meeting. The Committee was reminded that this case of a sudden death six months following the third dose of Gardasil vaccination was reported to CARM in November 2009 and was presented to the Committee at the 141st meeting held on 11 March 2010 (agenda item 4.1.1.5, minutes available from  www.medsafe.govt.nz/profs/adverse/Minutes141.htm#4.1).

 

The Committee noted that the Coroner's draft report includes a comment that death may have been due to an arrhythmic event secondary to undiagnosed cardiac pathology which remains a possibility. The family elected not to further engage in a clinical investigation of first degree relatives including parents and siblings. Based on the evidence, the Coroner commented that sudden arrhythmic death was a real possibility but there was insufficient evidence to elevate this possibility to a probability. The Committee expressed their sympathy for the family and noted that the Coroner's formal finding for the cause of death in this case was unascertained.

 

Recommendation 5

 

The Committee considered that there is no safety concern relating to the development of autoimmune conditions after HPV vaccination. Ongoing surveillance and reporting of adverse reactions to the Centre for Adverse Reactions Monitoring should continue.

 

Recommendation 6

 

The Committee noted the Coroner's findings that the cause of death in this case was unascertained but may possibly have been due to a cardiac arrhythmia.

 

To say we are disappointed would be the understatement of 2015. They have gone against global trends yet again, even though "the Committee noted that autoimmune conditions have a higher incidence during puberty and adolescence than in early childhood".

 

Our question is this: HOW MANY MORE GIRLS NEED TO SUFFER NEEDLESSLY BEFORE THEY WILL TAKE ACTION????

 

Let us pull apart their Minutes, bit by bit:

 

"Gardasil was shown to have very high efficacy in clinical trials." Have they not read the data that clearly shows that a saline placebo was not used in the Merck trials?

 

"One of the reasons why HPV vaccination starts at this age is to ensure that vaccination covers the peak risk period" - Really? Girls are at risk from a sexually transmitted disease at 12? That's not even legal!! And we are hearing that boosters might be required as they're not sure of the longevity of the vaccine!

 

"the Committee noted that autoimmune conditions have a higher incidence during puberty and adolescence than in early childhood." - So, let us get this clear .... there's a higher incidence already of autoimmune diseases at this stage of a girl's life, yet they'll add further unecessary toxins to aggravate things? 

 

"The Committee noted that autoimmune conditions include a wide range of conditions that have varying mechanisms of occurring. This was a limitation of some of the observational studies which grouped different conditions together. The difficulty in determining the onset time of these conditions also makes it difficult to perform these studies. However the additional sensitivity analyses and case investigation in these studies supported a lack of association" So, let's not accept that adverse reactions ARE being reported; let's just blindly continue to accept the "science" which says the vaccine is safe. Let us not proceed to actually conduct our own investigations like Japan and Denmark and the EU. The reason MARC has no studies showing causal links is because doctors will not accept that Gardasil is to blame. From the outset, they are closed minded in this regard; thus unless the mothers or girls complete their own CARM report, MARC is not hearing about it!

 

"The Committee were unanimous that based on the evidence presented, there is no safety concern relating to the development of autoimmune conditions after HPV vaccination." That's because doctors are NOT submitting evidence!

 

We are seeking further advice on the ruling and will report back here in due course. Rest assured that the last thing we will be doing is accepting this nonsense!

 

 

 

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