New Zealand's Gardasil stories
These are a few more of the Gardasil stories that just won’t go away. This time the focus is on the deaths of two New Zealand teenagers, and the sudden and dramatic damage done to the health of several other fit, healthy teenage girls.
On Monday 9 November 2015 TV3’s 3D programme featured interviews with the New Zealand families at the centre of New Zealand’s untold Gardasil stories.
HPV vaccine and the school-based vaccination programme: A mother and daughter share their story
A mother and daughter agreed to share their story of how the pressure to participate in the Gardasil school-based vaccination programme led to a full-scale argument between them and ongoing hostility.
The daughter, Kay * is in Year 8 at a primary school. Earlier this year, Kay, together with her friends, attended the education session run by the public health nurse at school about the ‘cervical cancer’ vaccination programme. Kay watched the DVD and listened to what the public health nurse had to say. Some months down the track Kay didn’t remember that much information from the DVD but she specifically recalled the girl coming home with the consent form for her mother, and the girl telling her mother she had to get it done. Of the presentation given by the public health nurse, Kay felt there was statistical information that wasn’t easy for her to understand; the public health nurse talked mainly about “how easily you can get it” and that it was important to “have it done.” Kay and her friend “were frightened we would get cervical cancer if we didn’t get the jab.”
Kay’s mother, Wendy * recalls Kay coming home and saying it was really important to be vaccinated and that “she had to get it done.” But Wendy wanted to delay any decision to vaccinate. She felt she still didn’t know enough about the vaccine and that in a couple of years time, when there was more data available, she would be better placed to make an informed decision. She was also concerned about the young age for vaccination, and the mixed messages around vaccinating against a sexually transmitted infection when it is illegal in this country to have sex under 16.
This disagreement led to a full-scale argument between Wendy and Kay.
Kay thought she had to “get it done” or she would get cervical cancer. She thought any of the additional information her mother raised with her regarding the vaccination programme was incorrect because she hadn’t heard it from the nurse.
Wendy filled out the Do Not Agree part of the consent form, indicating she would have Kay vaccinated at the doctor’s. But she acknowledged this was “a cop out” as she was wanting to avoid any potential confrontation with the public health nurse who might wish to challenge her decision. The consent form was returned to the school secretary.
Kay continued to pressure her mother about the decision. She falsely claimed she was the only one who wasn’t getting vaccinated to make her mother feel bad. She was under considerable pressure from her peers.
Nearer the time of the first round of vaccinations the school principal came into the classroom and made the girls who were being vaccinated, stand up in front of the class. She then made the girls who weren’t being vaccinated stand up, and each of them was asked, “why not?” Kay recalls feeling “stink” about this. It was nothing short of bullying on the part of the principal. What made it even worse was that her friends who were being vaccinated continued to ask “why she wasn’t getting it.” Kay said it made her feel as if her mother was going to let her get cervical cancer and perhaps die.
It’s not surprising there was ongoing anger and hostility between mother and daughter, given the lack of information, the misinformation, and the undue pressure that Kay was subjected to, not only from her friends but also the school principal.
It was only recently that both Kay and Wendy learned that Kay had until she was twenty years old to access the free programme. Immediately, the pressure came off, the hostility over the issue ended, and a more rational and informed discussion took place. And it was only then that Kay disclosed to her mother what the principal had done.
As phone calls to the AWHC office earlier in the year have confirmed, this story is not uncommon, and it highlights a number of very important issues:
- The risks of using a health promotion strategy that lacks balance, over-estimates the risk of developing cervical cancer, and is intended to frighten girls and young women into ill-informed compliance
- The failure to provide parents and caregivers with sufficient and balanced information to counter any misinterpretation of the information provided in the classroom setting
- The risks to family relationships when schools and public health nurses present information on vaccinations to students with the aim of gaining compliance rather than informed consent from both parents and their daughters
- The risks to students of being subjected to peer pressure
- The management within schools of the return and completing of consent forms
- The bullying by school staff.
The AWHC would like to thank both Kay and Wendy for sharing their story.
* Not their real names as their identities need to be protected.
GARDASIL IN SCHOOLS – BUT IS IT COST-EFFECTIVE?
As the economic situation worsens and the media peddles doom and gloom, the government is pressing ahead with its $160 million + school-based vaccination campaign to vaccinate all high school aged girls and young women. This despite the fact that there are still questions about the cost-benefit of the vaccine as well as whether it will be effective in reducing the incidence of cervical cancer.
In August 2008 an article by Dr Jane Kim and Dr Sue Goldie appeared in the New England Journal of Medicine on the health and economic implications of the HPV vaccine in the United States. It concluded that the cost-effectiveness of the HPV vaccine depended on achieving an extremely high coverage of preadolescent girls and whether the vaccine-induced immunity is lifelong (emphasis added).(1)
In the same issue of the NEJM, Dr Charlotte J Haug, editor of the Journal of the Norwegian Medical Association, wrote “Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer.”
Commenting on Kim and Goldie’s model she wrote “Their base-case assumptions are quite optimistic. They presume lifelong protection of the vaccine (ie, no need for a booster dose), that the vaccine has the same effect on preadolescent girls as on older women, that no replacement with other oncogenic strains of HPV takes place, that vaccinated women continue to attend screening programs, and that natural immunity against HPV is unaffected. If the authors’ baseline assumptions are not correct, vaccination becomes less favourable and even less effective than screening alone…With so many essential questions still unanswered, there is good reason to be cautious.” (2)
Diane Harper, one of the lead researchers on the vaccine, spoke on National Radio on Friday 1 August 2008 about her concerns over the pharmaceutical company’s marketing of the vaccine. She stated that there was evidence that the immunity to two of the HPV viruses that can cause cervical cancer was already showing signs of waning at 5 years. It is therefore extremely unlikely that this vaccine is going to provide the lifelong immunity needed to justify spending all these millions of dollars.
Last year the AWHC applied under the Official Information Act for information on the cost benefit analysis undertaken by the Ministry of Health on the HPV vaccine, but the documents sent to the Council had so many blank pages that it was impossible to ascertain what the facts were and whether the MOH had done their homework.
The AWHC has major concerns with the informational material being provided to parents, young teens, as well as the health professionals responsible for doing the actual injecting of the HPV vaccine. It is woefully inadequate, fudges important issues, and does not give accurate information about the concerns that some researchers have voiced about the vaccine. Last year a formal complaint was made to the Health & Disability Commissioner about the inadequate amount of information provided to parents during the MeNZB vaccination campaign, in the hope that the Ministry of Health would get its act together and undertake the Gardasil vaccination campaign with a heightened awareness of the need to strengthen the requirement to obtain informed consent and adhere to the standards required by the Code of Consumers’ Rights.
Unfortunately, the Gardasil campaign has all the hallmarks of the MeNZB vaccination campaign. Only this time the campaign is being conducted with aggressive marketing by the drug company, something that the New Zealand public was spared during the MeNZB campaign.
It therefore absolutely essential that parents and young women are told the following facts:
· 90% of those infected with HPV clear the infection within two years
· There is no proof that this vaccine will reduce the number of cases of cervical cancer
· Gardasil protects against only two of the dozen or so HPVs that can lead to cervical cancer
· Other varieties may in time come to replace HPV 16 and 18 as the major causes of cervical cancer
· Having regular cervical smears is the only proven method of preventing the development of cervical cancer
· In New Zealand deaths from cervcal cancer have reduced from 90 to 54 a year since the National Cervical Screening Programme (NCSP) was established in 1990.(3)
· Some researchers doubt that the immunity provided by the HPV vaccine will last much longer than five or six years
· Whether the Ministry of Health will pay for booster doses if needed
· As other countries have started vaccinating with Gardasil or Cervarix there have been increasing reports of a number of serious adverse events, including death (4) (5)
1. Jane J Kim and Sue J Goldie. “Health and Economic Implications of HPV Vaccination in the United States” New England Journal of Medicine. 21 August 2008 35;8 821-832.
2. Charlotte J Haug. “Human Papillomavirus Vaccination – Reasons for Caution.” New England Journal of Medicine. 21 August 2008 35;8 861-862.
3. NCSP 2006 Annual Monitoring Report June 2008.
4. Julia Brotherton et al. “Anaphylaxis following quadrivalent human papillomavirus vaccination.” Canadian Medical Association Journal 9 Sept 2008 179(6)
Father speaks out about HPV vaccine
In November 2008 the UK newspaper, The Independent, featured the following article by father of two Jerome Burne:
“Much as I love my two gorgeous daughters – aged 13 and 17 – and wish to protect them from all harm, I will not be consenting to them having the HPV vaccine against cervical cancer.
It's a public health initiative that is unnecessary, reckless and ridiculously expensive. Worse, serious doubts about its wisdom have not been properly presented to the public. Instead, children and parents have been bombarded with publicity – "a totally life-saving, revolutionary vaccine" – while the media have largely parroted official assertions that it is "safe, proven and effective", all of which are unfounded.
The outline of the project is pretty familiar. This term, "the biggest public health programme ever" began to vaccinate all 12 and 13-year-olds against the human papilloma virus (HPV): this involves three separate injections over several months. Later on, 16- to 18-year-olds will be inoculated as part of a catch-up programme. By July 2011, more than two million girls will have been offered the vaccine which, it is claimed, will protect them against the two strains of HPV – numbers 16 and 18 – responsible for 70% of all cervical cancers.
At the moment, 3,000 women develop cervical cancer every year and just under 1,000 die from it. Government and drug-company press releases claim that the programme will eventually cut these deaths by about 400 a year. What's not to like?
To begin with, it is a fabulously expensive way to deal with a problem which, although horrible for anyone who develops it, is hardly a major health risk. Figures haven't been widely publicised, but one quoted cost is £100m a year, which works out at £250,000 per life saved. Would this pass the NICE criteria for expensive cancer drugs? We already have a very effective screening programme that has brought deaths from cervical cancer down from 11 per 100,000 in 1950 to 3.4 in 2004, and the numbers are expected to continue falling.
However, the vaccination could actually reverse that. Women still have to be screened because, even when the whole programme is up and running, the number who develop precancerous cells is expected to drop by, at best, 50%. At the moment, the biggest risk factor for cervical cancer is never having been screened; half of those with the disease haven't. The fear is that the programme may reduce screening attendance as vaccinated women assume they are safe.
But these are arguments about the HPV vaccine as a public policy. What really matters to me and every parent is: what risk does it expose my children to? As we've seen that the chance that any individual girl will benefit is tiny, I want the risk of any adverse reaction to be even tinier.
Public discussion of risks in the UK gives little hint of possible dangers. (The figures that follow all relate to a brand called Gardasil being used in America. This was to have been the UK choice until one called Cervarix was chosen because it was cheaper. We are told that otherwise they are equivalent.)
We plan to vaccinate 600,000 12- and 13-year-olds a year, on the basis of trials involving fewer than 1,200 girls under 16 that lasted less than two years. More than 20,000 women aged 16 to 26 were also involved in trials. Side effects included birth defects and juvenile arthritis. Only a few; but what happens when millions get the vaccine? Could certain genotypes be particularly vulnerable? No one knows. In fact, I'm asked to enter my children into a vast experiment.
Already, patterns of side effects are emerging. A body called Justice Watch has been prising figures for adverse reactions to Gardasil from the US authorities. Last October, the total was around 3,500; by this July, the figure had risen to 8,864, including 18 deaths and 140 "serious" reports.
There's plenty of disagreement over what the cases show. Authorities say they aren't necessarily connected to the vaccine. Two of the most worrying reactions have been blood clots – what might that be doing if you are one of the older girls on the pill? – and 38 reports of an autoimmune disorder called Guillain-Barré syndrome that can cause paralysis.
It's obvious that we need more information, which is why the US Food and Drug Administration called for studies to investigate these possible risks. But the results won't be in for a decade in some cases. The quickest trial they asked for was one involving 44,000 vaccinated girls who are being followed for six months to pick up signs of any immediate or medium-term problems such as autoimmune disorders or rheumatism. The results will be out in September next year. Meanwhile, UK experts confidently declare that there are no dangers; if so, why run this and the other studies?
But the uncertainty over side effects isn't all that's unknown. A key factor in the success of any vaccine is the length of time it confers protection. If it is too short – say, less than 10 years – too many booster shots will be needed. How long will protection last? No one knows; so far, it's lasted six years.
Then there is the reaction of the 15 other HPV strains, which account for 30 per cent of the cancers; will that change as the two most infectious ones are blocked? Could it allow them to become more infectious? A recent paper in the New England Journal of Medicine explored the possibility. Will it happen? No one knows.
And on top of all that, we don't actually know that the vaccine will prevent cancer. We know it confers resistance to the virus strains most likely to cause cancer, but since the cancers don't usually appear until a woman is in her late forties, definitive proof will be some time coming.
So this great public-health initiative looks more like a hugely unstable edifice of wildly optimistic assumptions piled on top of one another. If just one or two prove way out, it could all come crashing down. It's one lottery I won't buy a ticket for.
HPV infects the majority of women, maybe as many as 80 per cent, by the age of 50 but it very, very rarely causes a problem. I believe that my girls will be a lot safer relying on healthy immune systems that haven't been challenged by too many vaccinations and on regular, cheap, simple and safe smear tests.”
Jerome Burne. The Independent 18 November 2008.
GARDASIL: AN EXPERIMENT ON GIRLS
The May 2007 issue of the AWHC Newsletter featured a report on the papers and articles that had appeared in the New England Journal of Medicine on the subject of human papillomavirus (HPV) and Gardasil, the HPV vaccine developed by Merck that had been undergoing trials. The HPV vaccine has been shown to be effective against two HPV types – 16 and 18 – that are currently responsible for around 70% of all cervical cancers.
Reversing the previous year’s decision not to introduce an HPV vaccination programme in the immediate future, then Prime Minister Helen Clark and Health Minister David Cunliffe announced that the programme will be offered free to 300,000 young women aged 12 – 18 years from September 2008. This can only be seen as another political decision based on the desire to win an election rather than on sound evidence.
In August 2007, a commentary expressing concerns about Gardasil appeared in the Canadian Medical Association Journal. It was written by Dr Abby Lippman of McGill University’s Department of Epidemiology, Biostatistics and Occupational Health, Dr Ryan Melynchuk of Dalhousie University’s Department of Bioethics, Carolyn Shimmin, and Madeline Boscoe from the Canadian Women’s Health Network.
In the article the authors noted that information about the efficacy of Gardasil remains uncertain, that relatively few girls were enrolled in the vaccine’s clinical trials, and that the cost of the vaccine is one of the most expensive proposed for mass use. The issues they raised are applicable to New Zealand and are quoted below using references to New Zealand instead of Canada:
There is no epidemic
There is no epidemic of cervical cancer in New Zealand to warrant the sense of urgency for a vaccination programme. Both the incidence and mortality of cervical cancer have been declining in New Zealand. However, the incidence and mortality still vary between different groups of women, being notably higher among Maori and Pacific women than European women.
Cervical cancer is slow to progress
Invasive cervical cancer typically follows a slowly progressive course that can be halted at one of various stages. It usually takes more than a decade to develop cervical cancer.
HPV clears spontaneously
Most HPV infections are cleared spontaneously. Recent research using available molecular detection tech-nologies has suggested that clearance occurs within one year for about 70% of infected women, and within two years for 90%. Thus, HPV infection and cervical cancer must not be conflated: cervical cancer will not develop in most women who are infected with even a high-risk strain of HPV. Unfortunately, there are no data on clearance rates among girls, nor even about the actual HPV prevalence rates among youth and young children, yet this is critical information for developing, and subsequently evaluating, policy proposals.
Aim of vaccination programme
What exactly is the aim of the vaccination programme? Is it the eradication of high-risk HPV types from the population? Or is it to reduce the number of deaths from cervical cancer?
If the goal is the former then it is necessary to vaccinate boys and young men. If the latter is the goal then there is a need for a vaccine that is directed against more than the two high-risk HPV types in Gardasil. It is important to note that the potential exists for other HPV types to emerge to take the place of HPV types 16 and 18 in causing cervical cancer, given that there are more than a dozen HPV types that have the ability to result in the development of cervical cancer.
Information about the efficacy of Gardasil remains uncertain. Its real-world effectiveness is even less clear. To date, only a handful of randomised controlled trials of sufficient quality to qualify for systematic review have been reported, and all of the reported HPV vaccine trials whether of Gardasil or its competitor Cervarix, were funded in whole or in part by the vaccine’s manufacturer.
Effectiveness of the vaccine
The length of immunologic protection offered by the vaccine is unknown. Will boosters be needed, and if so, when? Other questions concern the possibility of short-term immunity altering the natural history of viral infection, as seems to be the situation with chicken pox.
There is also a lack of data on the effectiveness of the HPV vaccine when co-administered with other immunisations. As well, will such factors as a person’s nourishment, smoking status and general health influence the safety or usefulness of the HPV vaccine?
Few young girls in trials
Relatively few girls under the age of 15 years of age were enrolled in the clinical trials of Gardasil, the youngest of whom were followed for only 18 months. Based on the assumption that they will not yet have been exposed to HPV viruses, girls in this age group represent the priority target population for mass vaccination. This is a thin information base on which to construct a policy of mass vaccination for all girls between 12 – 18 years.
Gardasil is the most expensive childhood vaccine proposed for mass use. Where is the cost-effectiveness analyses of this vaccination programme that are needed to evaluate this expense? Girls and women will still need to practise safe sex and have regular smear tests. What is the impact on other health care priorities of devoting limited resources to this HPV vaccination programme?
The article concluded with a number of general recommendations. They are that it must be publicly funded. However, before millions of dollars of public funding is diverted into such a vaccination programme, the broader issues of how public funds are used to promote and protect the health of girls and women must be considered – issues such as the needs of the marginalised and most vulnerable groups in society. Government support for HPV vaccinations must not perpetuate existing health inequities. Instead such programmes ought to reduce health inequities through thoughtful, comprehensive, evidence-based approaches that permit those most at risk to benefit.
It is too soon to be spending money on a vaccination programme targeting teenage girls when there is an urgent need for prompt and clear answers to the questions raised. We must be certain that spending $177 million to vaccinate a population of girls and women in New Zealand who are already mostly well protected by their own immune systems, safer sex practices and existing screening programmes, will not perpetuate the existing gaps in care and leave the actual rate of deaths from cervical cancer unchanged. Worse would be the emergence of iatrogenic effects, such as an increase in cervical cancer rates, if a false sense of security led girls and women to stop having regular smear tests and to view vaccination as a simple fix.
“Individual girls and women, as well as policy makers, can make truly informed decisions about vaccinations only when they have all the evidence, and today there are more questions than answers.”
Abby Lippman et al. Canadian Medical Association Journal. “Human papilloma-virus, vaccines and women’s health: questions & cautions.” 28 August, 2007; 177(5).
From AWHC Newsletter May 2008 "Gardasil: An Experiment on Girls"