On Friday June 10, my daughter came home from school very upset. We had not given consent for the Gardasil HPV vaccine that is being administered at the school this week and her friends told her she would get cervical cancer. The view of her 12 year old friends is understandable, the NHS letter distributed by the school recommending the vaccine, clearly states in its opening line; “Consent required for your daughter to receive the Human Papilloma Virus Vaccination to protect her against cervical cancer”, again the claim of protection against cancer is repeated again in the fifth line of the letter.
In April 2011 I was diagnosed with rectal cancer, in August 2013 I was told, my cancer was incurable and with chemotherapy the average live expectancy was 22 months. The fact I am still around and cancer free is another story, but the impression that I would not do everything possible to protect my daughter from this horrible disease has angered me. At the outset I should point out, none of my children have had any vaccines and we arrived at this decision in a perfectly logical manner which I have blogged about. I am not against vaccination as such, having seen the benefits they can have in third world countries where children don’t have access to clean water, are malnourished and sanitation is poor. If we had to live in Pakistan I would give them the Polio vaccine but there is zero risk in the UK of this disease or Diphtheria, and the risk is only likely to increase if we start pumping ray sewage into our rivers.
As s a child of the 60s, my friends and I had what were called “normal childhood illness”, measles, mumps etc and the vast majority of us had them without problems. These infections are no longer common largely because of vaccines, however mortality rates associated with these infections is a very different matter and another discussion, as are side effects associated with vaccines. What were “normal” childhood infections in the 60s and 70s, do seem to have been replaced by a whole range of chronic autoimmune disorders that can be managed with medicines, at great cost to the NHS and very profitable for the pharmaceutical industry whose primary legal duty is to shareholders not customers.
Having looked at the evidence for the Gardasil vaccine, the HPV vaccine used in the UK on children, I have come to a similar conclusion as Dr Dianne Harper who has changed her mind about the vaccine she helped develop. The HPV vaccines effect on cervical cancer rates are minimal, the immunity it creates in 12 year olds, d
oes not last out of the teens , it does not protect against all cancer causing viruses and the vast majority of the population who are sexually active will come in contact with this virus at some time in their life and will not develop cervical cancer.
A recent study published in Cancer Epidemiology, Biomarkers & Prevention in 2015, a journal of the American Association for Cancer Research showed Vaccination rates against human papillomavirus are far lower (38%) than rates for other routine childhood (90%) and teen immunizations. Interestingly it’s not hesitant parents refusing the vaccine that is causing the problems with uptake, rather “primary care doctors treat the HPV vaccine differently from other routinely recommended immunizations, hesitating to recommend it fully and on time and approaching their discussions with parents differently”. Fifty nine percent said they approach discussions by assessing the child’s risk for contracting the disease rather than consistently recommending it to all children as a routine immunization.
A recommendations in the study for improving uptake of the HPV vaccine is the need to make the vaccine not about sex but about routine cancer prevention. This is where the emphasis for twelve year old girls rather than not engage in sex, but if one choses to risk sex make sure you have cervical screening when you are 25 and avoid other risk factors.
According to the Centre for Disease Control (CDC), these factors are:
- Having HIV or another condition that compromises the immune system.
- Using birth control pills for a long time.
- Having given birth to three or more children.
- Having several sexual partners.
- Uncircumcised penises
When assessing any medical intervention you weigh up the benefits against the risks. The benefits of this vaccine to my 12 year old are: Should she become sexually active in the next few years and ignores all the advice on risk factors of sexually transmitted diseases, she may come into contact with the HPV virus. A virus that more than likely she will have contact with one day, whether she is vaccinated or not. As with all cancer the risk increases as we get older and the most effective way to prevent cervical or any cancer, is not to smoke, not to become obese, adopt a healthy active lifestyle and develop an effective immune system.
The vaccine does prevents genital warts, which no doubt is embarrassing for a teenager, however one could also argue that the red flag of genital warts, should make these women vigilant with their cervical screening, which has dramatically reduced incidence of cervical cancer since the 70s. Arguably the vaccine may provide a false sense of security, to young women at a high risk of cervical cancer.
Approximately 3,000 women are diagnosed with cervical cancer in the UK each year. According to Cancer Research UK cervical cancer is the 12th most common cancer in females and accounts for less than 1% of all cancers. 50% of the diagnoses are in women under 45.
As with most “Vaccine preventable Diseases”, mortality rates from the diseases had decreased significantly by the time vaccines became available. According to Cancer Research UK; Cervical cancer mortality rates decreased by 71% between 1971-1973 and 2010-2012. Mortality rates fell steadily throughout the 1970s and 1980s and then, more rapidly after improvements to the national screening programme in the late 1980s (decreasing by 43% between 1987-1989 and 1997-1999). This dramatic decline has mainly happened in women over 50. this despite the fact In situ cervical carcinoma incidence rates have increased by over 300% since the late 1970s
Could this vaccine be seen as a substitute for screening where the young children at highest risk of exposure to the HPV virus are probably the least likely, because of socioeconomic factors to take precautions to reduce risk of developing cancer.Cervical cancer in England is more common in females living in the most deprived areas
I suspect the hope of politicians always looking to reduce heath spending, is that one day the vaccine might be a cheap replacement for screening.
In young women the risk from cervical cancer is very small. Between 2010 and 2012 there was .3 deaths out of every 100,000 women aged between 25 and 30 and 1.5 deaths aged between 25 -34. Cervical cancer takes many years to develop, changes take place in the cells of the cervix. These changes are called cervical intraepithelial neoplasia (CIN). CIN is not cancer. However, you may hear some doctors or nurses describing it as a pre-cancerous condition. This is because if it is not treated it might develop into cancer. Most women with CIN do not develop cancer, and if treatment is needed for CIN it is nearly always effective. The most common age group for picking up these abnormal cells is between the ages of 25 -30 so screening is vital for preventing cervical cancer.
The NHS explains that cervical screening does not begin until women are 25 because “Cervical cancer is very rare in this age group”; according to them “The risk of cervical cancer is very low in women who have never had sex, the risk is so low, women in this group may choose not to have cervical screening when invited. Women aged 65 and over whose last three test results were normal aren’t invited for further cervical screening tests, because it’s very unlikely that women in this group will go on to develop cervical cancer”.
Right now schools like my daughters are asking parents to fill out a “consent form” for the HPV vaccination to be administered “within 7 days”. This does not leave much time to think about the decision, do research or speak to other parents who may have concerns and why would you, the marketing of a “Protection from cancer” is a compelling argument.
According to the Medical Defence Union (MDU), who advise doctors on matters of consent “ doctors and other health care professionals have a duty to explain to patients, in non-technical language, the nature, purpose, and risks of a proposed procedure”. The MDU goes on to say “The doctor undertaking an investigation or providing treatment should usually talk to the patient but may delegate the discussion to someone who is suitably trained and qualified and who understands the proposed treatment and its risks. (In this case its the nurse and the school). The treating doctor is still responsible for ensuring the patient has been given the necessary information and time for their consent to be valid”
The information provided to Parents in the NHS leaflet “Your guide to the HPV Vaccination” is completely inadequate for the purpose of consent. It describes “side effects” as “mild” soreness, swelling, and makes a cursory reference to serious side effects as being extremely rare. The problem with this approach is how does one monitor side effects if parents are unaware of what “serious reactions” could be. In 2000 Sally Clarke was convicted of murdering her son The 6 month old boy died in his sleep 3 hours after he had had his DPT vaccine. She was completely unaware of the possibility of severe reactions to this vaccine and it was only raised on second appeal some years later. Her own medical experts during the original trial would not even consider the possibility when there had been a number of deaths in America and the UK after this vaccine.
Parents in Japan, Ireland and Denmark had no idea there were problems with the vaccines in the initial trials, then wonder what happened to their child, eventually it reaches a critical mass victims start meeting and sharing their stories. In the UK the public is given very little information of possible side effects from Vaccines. Parents of vaccine damaged children have had to take on Governments and the Pharmaceutical industry by themselves seeking justice for their injured children.
Perhaps we should have smelled a rat in 1979 when the UK Government absolved the pharmaceutical industry of responsibility for vaccine injury with “The Vaccine Damage Payment Act” after Rosemary Foxes campaign after her daughter was damaged by the Polio vaccine in 1962. She begins her book with; “How would you feel blessed with a
happy healthy baby daughter and overnight she is transformed into one that could never be normal, who suffers permanent mental handicap and convulsions. Then as you sought explanations and challenge the Governments refusal to award compensation, you are told you are damaging the vaccination programme and had to keep quiet” ( Helens Story; by Rosemary Fox: Amazon). The governments “scientific evidence” states vaccines are safe, can one can always trust “scientific evidence” ? How could anyone forget the government minister John Gummer feeding a burger to his daughter because the scientists told him British Beef was safe and would not cause BSE.
“Many physicians and parents consider immunisations routine; as a result, they fail to discuss this important aspect of health care. Parents should be educated about each vaccine and the role it plays in the well-being of their child. To ensure that parents will be able to give informed consent to have their child immunised, the physician should provide information on the nature, prevalence, and risks of the disease; the type of immunisation product to be used; and expected benefits; risk of side effects…”
This led to a much more comprehensive approach to gaining consent to vaccinations in the US, the fact it is a vert litigious society probably had a lot to do with it. In the US parents must read and sign Vaccination Information Sheets (VIS) before vaccine can be administered to children. The VIS for Gardasil does have more information on serious side effects that the UK leaflet and the fact, details of serious events are not mentioned, brings the consent to Gardasil into question
No doubt the American approach may encourage people with unrelated conditions to believe there is a connection to vaccines and drugs they have received. As of Sept 2015, there were a total of 37,474 vaccine reaction reports made to the federal Vaccine Adverse Events Reporting System (VAERS) associated with Gardasil vaccinations, including 209 deaths. In addition there were 3,119 vaccine adverse reaction reports made to VAERS associated with Cervarix vaccinations, including 16 deaths, this may seem a small percentage out of 57,000,000 doses, but if its your child its is 100% and, from what I have said above, no doubt some of these reports are coincidental and unrelated to the vaccine but “all of them”??
As of June 2016 , there had been 316 claims filed in the US for serious injury following HPV vaccination. The claims are made to the federal Vaccine Injury Compensation Program (VICP) , including 14 deaths; 92 of the claims have been dismissed, while 95 have been compensated so far. It is not clear how much was awarded for Gardasil specifically but so far in 2016, 417 awards have been made for supposedly safe vaccines to the tune of $154 million. I dont believe any risk of this magnitude is worth taking for preventing genital warts in sexually active teenagers.
Having searched the NHS website I did eventually find more information on serious side effects I am certain parents who have consented to this vaccine will be surprised to read that;
“It is not possible to reliably estimate how frequently other side effects occur. This is because information is received from people reporting side effects themselves, rather than controlled, clinical tests.
The frequency of these side-effects is unknown:
- blood problems, leading to unexplained bruising or bleeding
- fainting or brief loss of consciousness
- feeling dizzy
- general feeling of being unwell
- Guillain Barré syndrome
- joint pain
- muscle pain or tenderness
- seizures (fits)
If you feel unwell or have concerns about a side effect after having the HPV vaccine, seek medical advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist or nurse.
In rare cases, it is possible for someone who has had the HPV vaccine to experience a more severe allergic reaction, known as anaphylactic reaction. Signs of an anaphylactic reaction include:
breathing difficulties and wheezing
swollen eyes, lips, genitals, hands, feet and other areas
a strange metallic taste in the mouth
sore, red, itchy eyes
changes in heart rate
loss of consciousness
In June 2013, Japan’s Vaccine Adverse Reactions Review Committee (VARRC) suspended recommendation of the vaccine due to fears of adverse events. This is a sensible approach that normally happens when there are health concerns and is called the “precautionary principle” to risk management: That if an action or policy has a suspected risk of causing harm to the public, or to the environment, in the absence of scientific consensus, the burden of proof that it is not harmful falls on those taking an action that may or may not be a risk. In 2014 the International Symposium on the adverse reactions experienced by girls who have been vaccinated by Human Papillomavirus vaccines took place in Tokyo.
Dr. Sin Hang Lee who was presenting at the Symposium has accused members of the Global Advisory Committee on Vaccine Safety (GACVS), the World Health Organization, the CDC and other scientific/health professionals of deliberately setting out to mislead Japanese authorities regarding the safety of the human papillomavirus (HPV) vaccines.
In April of 2014 a French medical doctor Bernard Dalbergue, a former pharmaceutical industry physician with Merck, the manufacturer of Gardasil stated in an interview; “I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.”
A blog by Dr Nevile Wilson a medical doctor reviews much of the evidence supporting the vaccine and is very critical, and raises issues in a number of countries.
In Ireland hundreds of people have come forward after a TV Programme “Cervical Cancer Vaccine – Is it safe”? (2 parts), it highlighted the experience of four teenage girls after receiving the vaccine, these women have formed a support network called REGRET; Dr. Kevin Connelly, of the National Immunization Advisory Committee, refused to accept that any of these reported adverse effects were linked to the Gardasil vaccine, “The vaccine is safe, its just coincidence”, the Irish Department of Health have confidence in the EMA . This story was repeated in Denmark on Danish TV however their experts seem to have taken a different view of the EMA conclusions and their report from May 2016 is the most damning and credible criticism of the vaccine that I have seen to date.
Denmark introduced the HPV vaccine in 2009 and saw a similar upward trajectory of compounding severe adverse reactions. The Danish Health and Medicines Authority demanded the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee’s (PRAC) reassess the safety of the HPV shot. However, the committee’s review in 2015 did not change the agency’s position. The Press Release by the EMA, reveals a strong bias in favour of HPV vaccine safety, and ignores the many reports of vaccine harm being reported and that the “benefits of HPV vaccine continue to outweigh the risks”.
These conclusions were challenged in a report by medical experts from the Nordic Cochrane Centre in Copenhagen in May 2016. The report opens with the comments
We are concerned about the EMA’s handling of this issue as reflected in its official report ( and ask the EMA to assess:
1. Whether the EMA has been open and accountable to the citizens and has respected their rights to know about the uncertainties related to the safety of the HPV vaccines.
2. Whether the EMA has lived up to the professional and scientific standards that must be expected of the agency to guarantee that the administration enjoys legitimacy when evaluating the science and the data related to the safety of the HPV vaccines.
On page 12 of the report it refers to methods used to massage results in clinical trials, similar to methods used in the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm.
The report questions the prevailing assumption, that the vaccine is so important for public health that it is justified not to communicate to the public that there are uncertainties related to vaccine safety
The report states the methods used are; “totally unacceptable and contrary to good scientific practice to such a degree that we consider it outright scientific misconduct committed by the EMA…”
…The EMA’s procedures for evaluating the safety of medical interventions – where the companies are by and large their own judges – need to be fundamentally reworked and all procedures and information should be made transparent to the public. Our societies should no longer accept that assessments of drug safety are left to companies with huge financial interests and to a drug agency that receives 80% of its funding from the drug industry.
The secrecy imposed by the EMA is not in the public interest. Drug regulators tend to have a narrow vision, either because of their remit or because they have become too close to the drug industry by their daily work, which often involves contacts with the industry, and by employment of people with long careers in the industry.
Public health is about the promotion of health and prevention of disease and disability through the organised efforts of society. This entails protection from harms and involves progression of knowledge in open collaboration. As far as we can see, the actions of the EMA in this case indicates that the agency is more concerned about protecting its own previous decisions and the vaccine than about protecting the citizens and giving them the option of choosing for themselves whether or not they would like to get vaccinated against HPV.
Some people will prefer to avoid the vaccine, even if the risk of serious harm is very small, and some will prefer screening instead. It is not within the powers of regulatory authorities to deny citizens’ right to make informed choices about their own health by withholding important information. The citizens need honest information about the vaccine and the uncertainties related to it; not a paternalistic statement that all is fine based on a flawed EMA report
There are loads of anecdotes on the internet critical of the HPV vaccine and Gardasil in particular, if you search enough. Yes some of these reactions may be coincidental but they all cant be, the site www.sanevax.org also has lots of information. Bottom line is if you are concerned about your child getting genital warts have the vaccine, if your concern is cervical cancer make sure she is screened at 25.