“We can now prevent cancer. You can stop your kids getting infected with this cancer-causing virus. It’s staggering,” says expert.

RE: Vaccine could almost eradicate cervical cancer, experts say

The lead author and Medical Director of the National HPV Vaccination Program Register, Associate Professor Julia Brotherton is quoted in the Herald Sun: “We can now prevent cancer. You can stop your kids getting infected with this cancer-causing virus. It’s staggering.”

Brotherton’s enthusiastic statement comes as The Pharmaceutical Benefits Advisory Committee (PBAC) decides whether to replace the Human Papilloma Virus (HPV) vaccine, Gardasil with the two-dose Gardasil 9 for early secondary students.

Wording is important. The PBAC lists Gardasil 9 as a vaccine for the prevention of HPV. It may well be that these vaccines do prevent HPV but the question is whether they will ever prevent a single case of cervical cancer, a very slow-growing cancer easily detected during Pap smear testing with the five year survival rate for women diagnosed being 72%. There is no epidemic of cervical cancer in Australia. In 2014, there were 223 Australian deaths due to the disease.

The Pharmaceutical Benefits Advisory Committee (PBAC) will shortly decide whether Gardasil 9 is to be listed on the Australian National Immunisation Program as a 2 dose schedule replacing the current 3 dose Gardasil vaccine. Parents who are considering whether HPV vaccines are right for their children need to be informed that the new vaccine Gardasil 9 contains more than twice the amount of aluminium, a neurotoxin, used as an adjuvant to stimulate the production of antibodies, than the current vaccine. Gardasil 9 also contains more antigens (the HPV LI proteins) with the total number increasing from 120 mcgs to 270 mcgs. How will additional antigens and more aluminium affect the health of these young people who are now told they need this new vaccine?

Parents of teenage children need facts not empty promises. We do not know if Gardasil 9 can prevent cervical cancer. Human Papilloma Virus (HPV) vaccines have never been tested against cervical cancer outcomes. It can take decades from HPV infection to the development of cancer so researchers used a surrogate endpoint to support the conclusion that HPV vaccines might be preventative. The suitable surrogate end-point chosen was cervical intra-epithelial neoplasia (CIN) grade 2/3 lesions, and adenocarcinoma in situ. This end-point was decided even though these precursor lesions are common in young women under 25 years and rarely progress to cancer. In sum, very few of these CIN 2 and 3 lesions in young women develop into cancer so it is difficult to support their use as end-points or markers.

What this means is that all over the world millions of girls and now boys are injected with a vaccine which has only been measured against a surrogate endpoint — precursor lesions — that most often do not lead to cervical cancer. While the efficacy of the vaccines is unknown what we do know is that according to Vigibase, the World Health Organisation’s database there are now over 73,000 recorded adverse events after HPV vaccination. There have also been at least 324 deaths following Gardasil.

Parents need the facts in order to make an informed choice whether Gardasil or Gardasil 9 is right for their child.

See: Gardasil: Fast-Tracked and Flawed by Helen Lobato

 

 

Where’s the debate?

What health official in their right mind is willing to anticipate 2,300 serious adverse events to try and prevent 7.9 cases of cervical cancer? asked Norma Erickson, in her article FDA approved Gardasil 9: Malfeasance or Stupidity?

Serious adverse events  are defined as death, life-threatening events, hospitalization, disability or permanent damage. According to information on the Gardasil 9 package insert, for every 100,000 people using Gardasil 9 there would be 2,300 serious adverse events. This is a huge risk to take for a disease that affects 6-8/100,000 women in Australia, or 7.9/100,000 in the United States.

Gardasil 9, said to be protective against infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was approved by the US Food and Drug Administration (FDA) in December 2014. It was approved without the usual review process that is usually undertaken by the Vaccines and Related Biological Products Advisory Committee. In the clinical trials funded by the manufacturer Merck, a placebo was not used but instead trial participants received either Gardasil 9 or the quadrivalent Gardasil. The package insert reveals that in the case of the quadrivalent HPV vaccine, the original Gardasil, for every 100,000 people receiving the vaccination there would be 2500 serious adverse events – more than is expected for the new Gardasil 9. As we now know thousands of girls and boys are becoming very unwell after their HPV vaccinations. We are seeing this right across the globe after 10-11 years of HPV vaccination. According to Vigibase, the World Health Organisation’s database there are now over 73,000 recorded adverse events after HPV vaccination. And this figure is regarded as not accurate for so many events are not recorded. The correct figure is estimated to be closer to double that number.

The Pharmaceutical Benefits Advisory Committee (PBAC) will shortly decide whether Gardasil 9 is to be listed on the Australian National Immunisation Program as a 2 dose schedule for females and males aged 12 -13 years as part of a school age program for the prevention of HPV. This will replace the current 3 dose schedule of the 4 valent HPV, Gardasil vaccine. This is not a good move for Gardasil 9 contains more than twice the amount of aluminium, a neurotoxin, used as an adjuvant to stimulate the production of antibodies. The current HPV vaccine Gardasil has 225 micrograms of aluminium per dose whereas each dose of Gardasil 9 contains 500mcgs. Gardasil 9 also contains more antigens (the HPV LI proteins) with the total number increasing from 120 mcgs to 270 mcgs. Do we know the effect of these changes? How will increased antigens and more aluminium affect the bodies of these young people who are told that they need this vaccination for a disease they are most unlikely to ever get.

Wording is important. The PBAC listing information uses the phrase for the preventi0n of HPV. It may well be the case that these  vaccines do prevent HPV but the question is whether they will ever prevent a single case of cervical cancer. HPV is a common virus, one that is even found in newborns. It is also a virus which is naturally dealt with by the body’s immune system within 2 years. Cervical cancer is a very slow-growing cancer. It is detected during Pap smear testing. There are around 900 cases of the disease in Australia each year and the death rate is around 200.

Surely the public should be given this information? Doctors must understand the risks and explain these to the recipients as part of the process of informed consent. The ill-health and death ensuing from HPV vaccination is likely to worsen with the listing of Gardasil 9 on the National Immunisation Program. Such bad news should form part of our public debate but it isn’t.

See: Gardasil: Fast-Tracked and Flawed

 

 

 

Gardasil 9

An application has been made by Seqirus Australia to the Pharmaceutical Benefits Advisory Committee to list Gardasil 9 on the National Immunisation Program as a 2-dose schedule for females and males aged 12-13 years as part of a school age program for the prevention of the human papilloma virus HPV. This listing if approved will replace the current 3-dose schedule of Gardasil, the 4-valent HPV vaccine. The committee whose role it is to recommend new medicines for listing on the PBS is due to meet again in July 2017.

Gardasil 9 which was approved for use in Australia by the TGA last year is said to be protective against nine HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58. On the Gardasil 9 page of Merck’s website, the slogan: Your Child Could Be One Less At Risk For Certain HPV-Related Cancers And Diseases is prominently placed beside several happy, sporty children. Below is the directive to caring parents which reads ‘Help Protect Them With The HPV  Vaccine’. However if this vaccine is anything like its predecessor the 4-valent Gardasil, it is likely to be anything but protective. Currently there are tens of thousands of young girls who have become very ill after having their Gardasil shots. Sanevax records the numbers of young people injured and those who have died after HPV vaccinations. These are figures from the United States recording system VAERS and currently the numbers of adverse events are over 50,000 along with 317 deaths. These numbers are mainly from the USA and some parts of Europe and so these totals are far from accurate. Gardasil is authorised for use in 130 countries and 205 million doses have been administered. One would hope that this carnage could not continue and that the HPV vaccinations programs put on hold but instead there is another vaccine in the mix. Far from being protective this new HPV vaccine contains even more aluminium than the current HPV vaccine Gardasil which contains 225 micrograms.  One shot of Gardasil 9 has 500 mcg of this neurotoxin. Girls and boys will receive two shots of this new HPV vaccine bringing the total amount of aluminium injected into young bodies up to 1000mcg.

In FDA approved Gardasil 9: Malfeasance or Stupidity?, Norma Erickson has examined the Gardasil 9 package insert where she found that the rate of serious adverse events in  the trials of Gardasil 9 was 2.3-2.5%. Doesn’t sound bad but it really is because it means that for every 100,000 people who are given Gardasil 9 there will be 2300 serious adverse events and yet the cervical cancer rate in the US is around 7 women per 100,000. Talk about insanity!

And that’s not all she found when she examined the insert package. During the trials 2.4% of the recipients developed an autoimmune disorder which means that 2400 people could now be suffering from new diseases just because they had this new Gardasil injection. There was also bad news for women who became pregnant during the trials in that 14.1% suffered adverse outcomes. Erickson notes that those who were in the 4-valent Gardasil trials suffered similar and even higher rates of adverse outcomes of 17%. In all  313 women either lost their babies to spontaneous abortion or late fetal death or gave birth to children with congenital anomalies.

Will Gardasil 9 be listed on the PBS after July this year? Or will the PBAC whose job it is to recommend medicines for listing disapprove Seqirus’s request as occurred in November 2006 when CSL applied for the listing of  the 4-valent Gardasil? On that occasion the decision not to recommend Gardasil was overturned when Prime Minister John Howard stepped in and promised the public that the vaccine would be approved. In the interests of our children and grandchildren we can hope that Gardasil 9 is not listed on the PBS and if it is we will have to be even more vocal in our opposition to this unnecessary vaccination program that has so far failed to prevent one case of cervical cancer.

 

 

 

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