Cervarix Vaccine Programme to Cost UK Government £5.5 Billion Over 73 Years Before Targeted Annual Number of Women’s Lives are Saved.
FOR IMMEDIATE RELEASE
PRLog (Press Release) – May 18, 2011 – Let’s bypass the usual conversation on arbitrating a price on the value of a person’s life. The Cervarix programme in the United Kingdom may become bankrupt before even saving one woman’s life from cervical cancer.
Freda Birrell, Secretary of SANE Vax Inc. has been communicating with government officials in the United Kingdom for the past two years about the global concerns regarding the safety and efficacy of the HPV vaccines. Unfortunately, it appears the UK government just like the U.S. CDC and FDA – do not perceive the value of their constituent’s lives; nor do they appear to be concerned over the death and injuries of previously healthy adolescent girls in their respective countries. Children are our future! When the government of any country turns their back on them, it is cause for great public concern.
Birrell determined if the life of a child is not valued by the government then it was time to analyze present information they can relate to – in this case a financial investment in a vaccine programme that will cost the UK government billions before a return is seen on their investment. Sad but true.
Birrell and her analytical team have compiled data and graphs from Cancer UK Research on cervical cancer mortality rates in a document titled: HPV 2 Cervarix Economic Costs in the United Kingdom.
The analytical team developed an economic formula to determine the cost of the Cervarix programme to the UK government by using Cancer UK Research data and making basic assumptions on cost of vaccination for targeted demographic per annum. By doing so, they determined how long it will take before perceived benefits/results of the vaccination programme will be apparent. The data translates into a hefty financial subsidy benefiting GlaxoSmithKline, but an alarmingly low rate of return for the UK government and its citizens.
HPV 2 Cervarix Economic Costs in the United Kingdom [visit http://sanevax.org/news-blog/wp-content/uploads/2011/05/ ... for more information.]
According to Cancer Research UK – female mortality rates from cervical cancer rise slightly between ages 20 to 24 – but do not peak until age 45 to 49 – with the greatest increase in women over the age of 80. (Table 1 & 2)
Cancer Research UK reports mortality rates from cervical cancer decreased from 8.3 deaths per 100,000 in 1971 to 2.4 deaths in 2008. (Table 3)
Analysis assumptions based on available data from Cancer Research UK and the UK government on the vaccination programme follows:
• Total deaths (Cancer Research UK) to age 84 at 837 per year.
• 75% of deaths saved with the vaccination program i.e. 628 per year. *
• Cost per person vaccinated – £200.00 assumed.
• Average no. of vaccinations administered per year (12 year olds) at 378,289.
• The Cancer Research UK deaths/5 year groups have been divided by 5 for an average annual figure of deaths due to cervical cancer.
• JCVI assumes HPV2 Cervarix vaccination efficacy will last 10 years. **
• It will take 73 years to vaccinate a total cycle of the female population (12 year olds to 84 year olds)
* Cervarix vaccine was introduced to protect against HPV 16 & 18, the two viruses associated with 70% of cervical cancer cases. There have been indications that this vaccine may provide additional benefits due to cross-reactivity.
** Booster shots not included in calculations
In a dramatic table, Birrell has compiled an Analysis of the Annual HPV Vaccination Programme that shows that the first deaths saved from cervical cancer – (based on administration of Cervarix to 12 year old adolescent girls in 2008) will not be seen until the year 2016 (1.2 deaths per 100,000) at a cost to the government of £75,657,800 annually with a total cost of £681 million.
In other words…over 75 million £ will have been spent each year on the vaccine programme for 9 years to save one life….which Cancer Research UK has shown to be the mortality rate for this age group. (Table 2)
Now are you listening?
But wait there is more…according to Birrell’s research –
• It will take 28 years to save the first 628 lives, the annual target at a cost of £3.2 million for each life saved.
• It will take 73 years to save 628 lives annually – At a cost of £340,360 for each life saved.
The analysis also projects a total of 16,227 lives in the UK will be saved in total over the first 73 years – with an average of only 222 lives saved annually. In addition, it will take 240 years before the cost of a life saved falls below £150,000.
Add in the fact that the vaccine efficacy is only expected to last 10 years, meaning the girls first administered the vaccination series in their teens will need a booster in their 20’s…and so on up the ladder. Those pro-inflated costs and the costs associated with recommended annual pap screening were not included in Birrell’s analysis. Costs associated with vaccine adverse injuries were also not used in this equation.
Birrell was unable to uncover information in the public domain on the financial benefits to the UK government from this vaccination programme – justifiably raising serious questions over the Pharma/government agenda behind the HPV Vaccine programme.
Bottom line – bottom dollar – the UK government will spend £5.5 billion over the first 73 years of the vaccination programme with the expectation of saving 628 lives each year but with the current efficacy being only expected to last 10 years then these costs are grossly underestimated if a booster jab is introduced. If no booster jab is introduced and the efficacy falls at around age 22, it would render the previous ten years a total waste of public funds, accomplishing nothing more than giving false hope to all the participants who believed they would be ‘armed for life’ against cervical cancer.
SANE Vax Inc. can see no economic justification for this programme. We believe the UK government has been misled by the pharmaceutical industry regarding the risk to benefit profile of HPV vaccine programmes. Should other government leaders start doing the math regarding the cost of each life saved, we believe they would unveil HPV vaccination programmes as a colossal waste of public health funds with very few benefits to their constituents.
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Press Release:
http://www.prlog.org/11496237-cervarix-vaccine-programme-to-cost-uk-government-55-billion.html PDF File – HPV 2 Cervarix Economic Costs in the United Kingdom
http://sanevax.org/news-blog/wp-content/uploads/2011/05/SV-HPV-2-Cervarix-Economic-Costs-05.14.2011.pdf
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
Tuesday, May 24, 2011
Friday, May 6, 2011
SaneVax Inc. Protests FDA Approval of Second-Rate HPV Genotyping as a Cancer Test
Last week the FDA approved the HPV cobas test manufactured by Roche for HPV-16 and HPV-18 genotyping utilizing a probe-based technology for cervical cancer screening in the United States.
FOR IMMEDIATE RELEASE
PRLog (Press Release) – May 04, 2011 – This test was approved without a public advisory committee meeting, despite FDA regulations requiring such a meeting prior to the approval of any cancer diagnostic test.
Granting approval behind closed doors has denied American medical consumers’ access to any safety and/or efficacy data submitted to the FDA prior to their approval of this Class III ‘cancer screening’ test, contrary to prior FDA actions and current published guidelines.
According to one prior FDA Reclassification Order, “HPV test device shall therefore be retained in Class III, and is subject to premarket approval requirements.” (This includes at least one pre-approval advisory committee meeting open to the public.) The same FDA order also ruled, “…probe design is a critical process for HPV DNA testing because of the large number of closely related HPV genotypes. Complex probe cocktails may cross-react and/or compete with one another….”
A separate FDA Staff and Industry Guidance Document clearly states the FDA recommends any new HPV genotyping device be validated by an FDA-approved HPV test, or by PCR plus sequencing.
Both the National Cancer Institute and current scientific textbooks refer to DNA sequencing as the reliable method, or the ‘gold standard’ for HPV genotyping.
Based on research the SaneVax Team discovered in the public domain, approval of the HPV-16 and HPV-18 genotyping method used in Roche’s cobas device was not granted in accordance with the FDA’s own recommended protocol, or currently accepted scientific standards. This has made it virtually impossible to determine the validity/accuracy of Roche’s test.
The SaneVax Team received no response to their April 22, 2011 letter to FDA Commissioner, Dr. Margaret Hamburg, which emphasized one additional problem with the new ‘cancer screening test’ manufactured by Roche:
“The positive predictive value (ppv) of this cancer test for CIN3 (8.4%) was reported to be lower than the ppv for CIN2 lesions (14.0%). We all know a CIN3 lesion is more cancer-like than a CIN2 lesion. It is highly disturbing to learn that a ‘cancer test’ approved by the FDA appears to lose its positive predictive value as a precancerous lesion progresses to a more severe stage close to cancer.”
It appears the FDA has left medical consumers depending on a test that has not been proven accurate (validated), has not cross-checked results by using DNA sequencing, and exhibits accuracy (ppv) that diminishes as abnormal cervical lesions come closer to developing into cancer.
Should this ‘cancer test’ be marketed as a means to monitor HPV vaccinations, it will do nothing to prove HPV vaccine safety, efficacy or need.
Therefore, the SaneVax Team again requests the approval of Roche’s cobas HPV test be rescinded until the device is properly validated according to current FDA standards.
Sources:
1. View Roche's press release - http://www.roche.com/media/media_releases/med-cor-2011-0 ...
2. View Re-classification order - http://www.hifidna.com/News%20&%20Events%20files/Gutman+ ...
3. View Guidance for Industry and FDA Staff - http://www.fda.gov/downloads/MedicalDevices/DeviceRegula ...
4. View NCI HPV testing information - https://www.fbo.gov/index?s=opportunity&mode=form&id=da396b97ad6eb7ec4f7d511f85d9e325&tab=core&_cview=0
5. View textbook information on HPV testing - http://sanevax.org/news-blog/2011/04/hpv-genotyping-by-dna-sequencing-for-safe-and-necessary-hpv-vaccination-now-in-standard-textbook/
6. Read letter to FDA Commissioner - http://sanevax.org/news-blog/2011/04/hpv-genotyping-by-dna-sequencing-for-safe-and-necessary-hpv-vaccination-now-in-standard-textbook/
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
FOR IMMEDIATE RELEASE
PRLog (Press Release) – May 04, 2011 – This test was approved without a public advisory committee meeting, despite FDA regulations requiring such a meeting prior to the approval of any cancer diagnostic test.
Granting approval behind closed doors has denied American medical consumers’ access to any safety and/or efficacy data submitted to the FDA prior to their approval of this Class III ‘cancer screening’ test, contrary to prior FDA actions and current published guidelines.
According to one prior FDA Reclassification Order, “HPV test device shall therefore be retained in Class III, and is subject to premarket approval requirements.” (This includes at least one pre-approval advisory committee meeting open to the public.) The same FDA order also ruled, “…probe design is a critical process for HPV DNA testing because of the large number of closely related HPV genotypes. Complex probe cocktails may cross-react and/or compete with one another….”
A separate FDA Staff and Industry Guidance Document clearly states the FDA recommends any new HPV genotyping device be validated by an FDA-approved HPV test, or by PCR plus sequencing.
Both the National Cancer Institute and current scientific textbooks refer to DNA sequencing as the reliable method, or the ‘gold standard’ for HPV genotyping.
Based on research the SaneVax Team discovered in the public domain, approval of the HPV-16 and HPV-18 genotyping method used in Roche’s cobas device was not granted in accordance with the FDA’s own recommended protocol, or currently accepted scientific standards. This has made it virtually impossible to determine the validity/accuracy of Roche’s test.
The SaneVax Team received no response to their April 22, 2011 letter to FDA Commissioner, Dr. Margaret Hamburg, which emphasized one additional problem with the new ‘cancer screening test’ manufactured by Roche:
“The positive predictive value (ppv) of this cancer test for CIN3 (8.4%) was reported to be lower than the ppv for CIN2 lesions (14.0%). We all know a CIN3 lesion is more cancer-like than a CIN2 lesion. It is highly disturbing to learn that a ‘cancer test’ approved by the FDA appears to lose its positive predictive value as a precancerous lesion progresses to a more severe stage close to cancer.”
It appears the FDA has left medical consumers depending on a test that has not been proven accurate (validated), has not cross-checked results by using DNA sequencing, and exhibits accuracy (ppv) that diminishes as abnormal cervical lesions come closer to developing into cancer.
Should this ‘cancer test’ be marketed as a means to monitor HPV vaccinations, it will do nothing to prove HPV vaccine safety, efficacy or need.
Therefore, the SaneVax Team again requests the approval of Roche’s cobas HPV test be rescinded until the device is properly validated according to current FDA standards.
Sources:
1. View Roche's press release - http://www.roche.com/media/media_releases/med-cor-2011-0 ...
2. View Re-classification order - http://www.hifidna.com/News%20&%20Events%20files/Gutman+ ...
3. View Guidance for Industry and FDA Staff - http://www.fda.gov/downloads/MedicalDevices/DeviceRegula ...
4. View NCI HPV testing information - https://www.fbo.gov/index?s=opportunity&mode=form&id=da396b97ad6eb7ec4f7d511f85d9e325&tab=core&_cview=0
5. View textbook information on HPV testing - http://sanevax.org/news-blog/2011/04/hpv-genotyping-by-dna-sequencing-for-safe-and-necessary-hpv-vaccination-now-in-standard-textbook/
6. Read letter to FDA Commissioner - http://sanevax.org/news-blog/2011/04/hpv-genotyping-by-dna-sequencing-for-safe-and-necessary-hpv-vaccination-now-in-standard-textbook/
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
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