3

Cervarix HPV vaccine adverts are untrue and should be banned

.
.
.

Christina England
vactruth.com
2/2/2010

Part I

(Thank you to Grace Filby, UK, for the above photo. Also thank you for cheeky message added. Grace and Freda Birrell have campaigned for the removal of Cervarix and Gardasil for the past few years. )

Cervical cancer kills around 940 women in the UK every year and the majority of these women are over the age of 45 years. Although shocking, this is a comparatively low figure,compared to those dying from other cancers, the highest rate of death being those dying from breast cancer which kills around 12,000 people a year. Despite these relatively low figures, the UK Government is keen to make sure that every girl over the age of twelve is vaccinated with the new HPV vaccine Cervarix which was introduced to the UK in September 2008.

Cervarix is a vaccine that protects women against strains 16 and 18 of the sexually transmitted disease HPV or Human Papillomavirus which causes 70% of cases of cervical cancer and precancerous cervical lesions seen in women today.  Cervical cancer, is a cancer of the lower part of the uterus or womb and precancerous cervical lesions, are the changes in the cells of the cervix that have a risk of turning into cancer. Cervarix works by causing the body’s own defences to make antibodies against Human Papillomavirus types 16 and 18. Cervarix will not protect against all types of HPV only strains 16 and 18. Cervarix is currently used for females from the age of 10 years  onwards.

Many parents and young women however, are now questioning how necessary this vaccine is. This is due to the information recently released from Cancer Research UK, which states that cervical cancer is actually only the twelfth most common cancer in women in the UK and the majority of women who do die are over 45 years of age. They also state that over the last 30 years the numbers of those that have died with cervical cancer has actually fallen by two thirds. Parents have also questioned why a vaccine for sexually transmitted diseases is being offered to children as young as twelve and are worried that this is giving children the message that sexual activity at such as young age is OK some even naming the vaccine the ‘promiscuity vaccine’.

These facts are worrying many experts and some question whether giving the HPV vaccine to children as young as twelve is necessary and whether to wait until the child is older.

Dr. Diane Harper, a leading expert, involved in the original clinical trials for Cervarix says that this decision was not a scientific decision but a political decision.

“The age at which the vaccine is recommended is a political decision, not a scientific decision.” she told me in an email.

“Scientifically Cervarix has performed equally well in all efficacy tested ages from 16-26 years. Cervarix has also induced antibody titers in girls and boys 10-15 years and in women 16-26 years old that are equivalent to the titers seen in the 16-26 year old efficacy cohort which produces outstanding efficacy. Scientifically we also know that 10% of 10-11 year olds have already been infected with HPV and that there is no age at which all girls are not exposed to HPV.”

She continued to say that the Cervarix vaccine only helps to prevent the HPV infection, it does not prevent cancer. She feels that the PAP screening tests are equally as important as the vaccine and feels that in the long term PAP screening will prevent more cervical cancer than the vaccine itself.

She says:

“Pap screening has effected the early detection of cancer precursors, and treatment with excisional methods (leep, cone) has completely removed the pre-cancers, hence preventing cancers from developing.  Your population needs to continue with Pap screening as the vaccination will not prevent as many cancers from developing as will routine Pap screening.”

This is very different to what could be seen as the potentially misleading advertising that the UK government has endorsed.

The advert given to all GP’s at the beginning of the Cervarix campaign stated:-

“Cervarix helps you give women cervical cancer protection, with a strong and sustained immune response.”

This is seen by many as misleading and could have given many GP’s the false impression that this vaccine protects women from cervical cancer, when in fact it only protects women from HPV which is said to cause just 70% of cervical cancer.

The same information is found on many websites.

This is the information found on the Netdoctor website

“During 2008 and 2009 the UK has seen the widespread use of two new vaccines to prevent cancer of the cervix (neck of the womb): Gardasil and Cervarix”.

The recent NHS adverts not only lies but because of those lies it misleads young women into believing that the Cervarix vaccine arms them against cancer of the cervix, for life.

On several bus routes throughout the UK, adverts with the following information can be seen:-

“Arm yourself for Life

“The HPV Vaccine will help prevent Cervical cancer.”


This gives the strong and often misleading message that Cervarix protects women against cervical cancer for life and this is not what experts are saying.

Dr Harper makes it very clear that the vaccine does not prevent Cervical cancer.

She also says that Glaxo Smith Kline do not know how long the vaccine lasts as the trials are still ongoing. In an email she stated the following:

“Good News is that Cervarix is proven to protect women for 8.5 years and the trials are still ongoing. The antibody titers at this time are still very very high (as high as at 18 months after vaccination), so there is reasonable hope that the protection will continue for the necessary minimum of 15 years to offer true decreases in cancer.”

When asked her opinion as to whether she thought that the advertising campaign was falsely advertising the product she answered:-

“The ‘for life’ part has no facts, unless they are promoting screening. The data go out to 8.5 years.”

She is right of course, as Glaxo Smith Kline in their material, sent out to GP’s at the beginning of their campaign in the form of a GP Advert contains the information Duration and protection has not been fully established in other words the MANUFACTRERS of the actual vaccine, haven’t a clue how long it lasts for or even what protection it gives. So what I would like to know is how the NHS or the National Health Service in GB can advertise this vaccine with the words ‘Armed for Life’ or ‘Arm yourself for Life’ as they are currently doing. This is misleading the public and may be putting young lives at risk.

The adverts do mention screening in small print, however, when you glance at an advert it is usually as a whole and you notice the headline first. Whether you mention PAP screening or not, the fact remains, that this vaccine does not at present protect against anything FOR LIFE!

I was so outraged by these lies, that I took my complaint to the ASA or the Advertising Standards Authority. I have received a letter back from Susan Thomas Complaints Executive who says:-

“Firstly you object to the slogan ‘Arm yourself for life’ because you understand that it is not yet known how long the vaccine offers protection for. We have passed this matter to our investigations team for further consideration.”

Well it is a step in the right direction I guess.

I have also contacted my local Member of Parliament Mr Nick Gibb, who is the Shadow Minster for Education. He has also written to the Advertising Standards Authority. Mr Gibb is working very hard on my behalf to take this matter further.

The fact of the matter is, it is not just a case of my understanding that it is not yet known how long the vaccine offers protection for, it is a case of hard facts, no one knows not even Glaxo Smith Kline themselves. Surely they must have endorsed this advert, for it have gone ahead.

The Indian authorities feel that Glaxo Smith Kline are misleading the public in the way this vaccine is being advertised. The Drugs Controller General of India or DCGI;  the Drug Regulatory Authority of India has pulled up Glaxo Smith Kline Plc’s (GSK) for what they call “unlawful” propagation of its cervical cancer vaccine Cervarix, through mass media.

They state that Glaxo Smith Kline’s promotional advertisement campaign has appeared in different newspapers and on television channels announcing that the vaccine will be effective against cervical cancer and this contravenes the provisions of Indian drug laws.

The DCGI state that the Drugs and Cosmetics Act, 1940 and Drugs & Magical Remedies Act 1954, does not allow any claim to prevent or cure diseases in Schedule J of the Act, which includes cancer and the adverts they say does just this.

Under the Drugs and Cosmetics Act, drugs sold under prescription cannot be advertised and this includes vaccines. India only allows advertisement of over-the-counter (OTC) drugs.

Even though the GlaxoSmithKline adverts do not refer to the name of its product Cervarix anywhere in the ad campaign experts they report have said the following:-

“Those ads clearly claim that vaccination can prevent cervical cancer, so it doesn’t matter that they don’t name the vaccine.”

It is reported that DCGI Surinder Singh was quoted as saying:-

“They (GSK) say the vaccine will be effective for cervical cancer. This kind of advertising is not allowed,”

GSK were asked by the DCGI to withdraw promotional advertisements for the cervical cancer vaccine, because they believed the campaign to be violating certain norms.

A spokesman for GSK said “We have received a show cause notice from the DCGI regarding our disease awareness campaign on cervical cancer. We are in the process of responding to the same suitably,”

Sadly this leaves many parents and women very confused and questioning the true qualities of the Cervarix vaccine. How are parents expected to know who to trust when the information is conflicting and misleading in content?

Jeff John Aufderheide who runs the website VacTruth and wants the truth about vaccines to be told in full, feels that the wording of these adverts are little more a ‘slick advertising ploy‘, to ensure as many as possible are vaccinated.

“The mere notion that cervical cancer can be prevented with a vaccine is absurd. Only through

gimmicks, propaganda ploys, slick advertising and lobbying is GSK able to convince the suspecting women and mothers to ignore the laws of nature. Progressive studies in science have proven many times over that exercise, raw foods and hygiene prevent cancer, not vaccines.”

Jeffry John Aufderheide

http://vactruth.com

If Governments and the NHS endorse adverts which are misleading, how can we trust them? I also complained about the text message shown on the advert. The text said ‘I had my cervical cancer jab 2day, no probs. C U l8r xx. For many that is true but sadly this is not the case for everyone.

Carley Steele Stockport Manchester

Rebecca Ramagge – Surrey

Paige Brennan – West Midlands

Ashleigh Cave – Liverpool

Hattie Vickery – Devon

Lauren Smith – Surrey, Sarah Chandler – Surrey, Leah Mann – Nottinghamshire

Debbie Jones ‘daughter’ – Orkney

The above are all girls who have had adverse reactions, If the NHS, the Government and GSK had no concerns about Cervarix, then why show the text message? To me this is clearly an admission of guilt.

Susan Thomas from ASA in her letter says;

“Thirdly you object to the txt message displayed in the ad which states ‘Had HPV jab 2day, no probs, C U l8r xx’ You argue that this implies that the vaccine has no side effects. As the ad shows a txt message, it is clear that this is one person’s experience and not a guarantee that the vaccine has no side effects”.

True but she forgets it is an advert, it is not a ‘REAL TXT’ An advert is advertising a product. It is not real, therefore, it is ploy to draw people in. Anyone reading this advert will automatically believe it means there are no side effects.

The txt also states it is a Cervical cancer vaccine,it is not.

This is called a marketing technique.

The FDA has recently approved Cervarix for the USA. So now the USA will be lucky enough to have two HPV vaccines to choose from. Both Cervarix and Gardasil will be competing head to head in a ‘war of the vaccines’. The Food and Drug Administrators were seen to vote overwhelmingly in favour of Cervarix being safe and effective in women and children 10 – 25years. (probably read the UK ads)

“Panellists say newer studies suggest the vaccine is safe but they recommend follow- up studies to monitor miscarriages and inflammatory- muscular problems reported by a small number of patients.” Daily News – FDA approves second cervical cancer vaccine, Cervarix for preventing HPV in women The Associated Press. 10th September 2009.

This will have been recommended because of what is written in the CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document September 9, 2009 which I was lucky enough to receive a link to, through one of my colleagues from ICAP-International Coalition of Advocates for the People, from the Netherlands.

Once again it seems that women and children are just ‘lab rats’ for GSK to test on. It says in section 6

“Health Outcomes:-

Given the natural history of HPV disease, reduction in cervical cancer due to vaccination will take years and even decades. GSK has developed a model using a standardized approach (details of methodology are currently undergoing independent review by the Centres for Disease Control and Prevention [CDC]) in order to estimate how Cervarix may impact future cervical cancer incidence and related deaths in US girls and women.”

Further down in original studies it is interesting to note :- (SAE = Serious Adverse Event)

“Of the 43 subjects who withdrew due to SAEs, study discontinuation resulted from a fatal event in 28 subjects (11 subjects in HPV group and 17 subjects in pooled controls; one subject in HAV720 group withdrew because of the death of her child due to congenital heart disease). See Section 7.3.5 for further details of all fatal events reported all clinical studies in which Cervarix has been administered. The other 15 subjects withdrew due to non-fatal SAEs, none of which were considered as causally related to vaccination by the study investigator”

Also

“The most commonly individual SAEs reported during the vaccination period were:

– Spontaneous pregnancy loss (including incomplete and complete spontaneous loss and missed abortion) with 59 subjects (1.87 per 1000 subjects) in HPV group and 51 subjects (2.15 per 1000 subjects) in the control group,

– Appendicitis with 25 subjects (0.79 per 1000 subjects) in the HPV group and 27 subjects (1.14 per 1000 subjects) in the control group,

– Dengue fever with 10 subjects (0.32 per 1000 subjects) in the HPV group and 10 (0.42 per 1000 subjects) in the control group,”

I found the most worryingly results were deaths although these were played down.

“7.3.5. Deaths

In the analysis of all clinical studies in which Cervarix has been administered (up to the data lock-point of August 31, 2008), 37 subjects were reported with a fatal outcome:20 subjects of 31,472 subjects (0.64 per 1000 subjects) in the HPV group and 17 subjects of 23,700 subjects (0.72 per 1000 subjects) in the control group. The median interval between the date of last vaccination and the date of death was 1.5 years (range 30 days to 3.3 years). Of note, the mean duration of follow-up was 2.2 years in HPV group and 2.5 years in the control group.

A summary of the number of deaths by group classified by its underlying cause is presented in Table 34. All the atalities in vaccinated subjects occurred more than 1 month after the last study vaccine administration, with a median interval between the date of last vaccination and the date of death of 1.5 years (range 30 days to 3.3 years). Road traffic accidents (10 cases) and suicides (7 cases) were the most common underlying causes of death.

In the group that received Cervarix, the following case fatalities were reported:

Road traffic accidents (5 cases): with intervals ranging from 386 to 124 days from last vaccination to death,

Homicide (2 cases): with intervals of 217 days and 826 days from last vaccination to death,

Suicide (2 cases, one case reported as gun shot wound possibly related to suicide)with 148 and 686 days from last vaccination to death,

Neoplasms: gestational trophoblastic neoplasia (onset 151 days after last dose),ovarian cancer (onset 1,127 days after last dose) and cervical cancer (46 year old in Study HPV-015 with normal cytology at enrollment but HPV-18 DNA positive,developed metastatic cervical cancer 205 days after last dose; study population of HPV-015 mainly consists of healthy women but includes also a subset of women with previous history of HPV infection),

Autoimmune diseases (3 cases): systemic lupus rythematosus (SLE) with Candida sepsis (SLE pre-existing with renal complications 6 months after first dose leading to sepsis and eventually death 21 months after the first and only dose), inflammatory bowel disease (IBD) with pyoderma gangrenosum (IBD diagnosed 2 months after third dose with multiple complications and eventually a pyoderma gangrenosum with a fatal outcome 22 months after last dose) and Crohn´s disease with toxic megacolon and septic shock (Crohn´s disease diagnosed 16 months after second dose,complicated with toxic megacolon and septic shock with fatal outcome 17 months after the second and last dose),

Infectious diseases (3 cases): septicemia (onset 758 days after last dose), bacterial septicemia (onset 770 days after last dose) and acquired immune deficiency syndrome(onset 254 days after last dose),

Cardiovascular disorders (2 cases): vascular thromboembolism (onset 1167 days after last dose) and acute myocardial infarction (onset 485 days after last dose).

In the pooled controls group, the following case fatalities were reported:

Road traffic accidents (5 cases): with intervals ranging from 30 days to 862 days from last vaccination to death

Homicide: death 961 days after last dose

Suicide (5 cases): with 49 days to 817 days from last vaccination to death,

Neoplasms (2 cases): osteosarcoma (onset 165 days after last dose) and colon adenocarcinoma (onset 112 days after last dose)

Autoimmune diseases: insulin-dependent diabetes mellitus with diabetic ketoacidosis
(onset 154 days after last dose)

Infectious disease: septicemia (onset 650 days after last dose)

Unknown cause of death (2 cases): sudden death 67 days after last dose in a subject with medical history of valvulopathy and hepatopathy prior to vaccination and one case for which study staff read in a newspaper that the subject was found dead; as an autopsy report cannot be released until all forensic analyses are completed,insufficient documentation for a complete assessment of the diagnosis and the cause of death is available.

No safety signal has been identified based on medical review of these 37 individual case fatalities.”

The above information was taken from the report.

In my opinion this advertising campaign should be banned or at least be worded in such a way it gives the facts and information that is the truth. The more lies that the public become aware of the less they will trust not only the vaccines but the Governments and the Pharmaceutical industry.

Christina England, BA Hons
 

Comments are closed