Most of my adult life I have lived with the knowledge that I am at increased risk of cervical cancer. As a DES Daughter I have a lifetime risk of a rare clear-cell cancer of the cervix/vagina. This cancer, causally linked to in utero exposure to DES, is aggressive, symptomless and the usual Pap smear will not pick it up. I have to have an annual “DES examination” that involves colposcopy. (For more on the DES story: www.desaction.org.au )
In addition, also because of my DES exposure, I have a 4-fold increase risk of squamous-cell cancer of the cervix – the cervical cancer the Pap smear is designed to detect.
Since first finding out I am a DES Daughter (nearly 30 years ago) I have learnt to live with this risk, to put it into perspective and get on with my life. Part of this process involved becoming informed about cervical cancer by reading medical journal updates. More important, however, was the sharing of experiences with other DES daughters. In this way over the years members of DES Action have built up a unique knowledge base and “expertise” of cervical cancer, from the consumer perspective.
So when there was news of a “cervical cancer “vaccine being developed, we naturally were very interested and read up on it. However, the more we read, the less sense it made. It wasn’t a “cervical cancer” vaccine but a part-vaccine for HPV. The unanimous consensus we came to was “Why bother?” [As outlined in ‘Gardasil: All cost and no benefit.’]
We were very concerned about the “hard sell” the pharmaceutical industry was using to put pressure on the Government to have Gardasil listed on the National Immunisation Program.
But our greatest concern, based on our DES experience, was the lack of evidence of long term safety of the drug. Could Gardasil, like DES, be a time-bomb with serious, unforeseen adverse outcomes emerging months, years or even decades after the initial injections?
Here is an extract from DES Action’s newsletter DESPATCH, March 2007:
Gardasil: Hype & Hard Sell
by Marian Vickers
Last November saw the most extraordinary example of manipulating the media for commercial gain when CSL, which shares Australian marketing rights for Gardasil with Merck, orchestrated the listing of this new cervical cancer vaccine on the National Immunisation Program.
CSL’s initial proposal was rejected by the Pharmaceutical Benefits Advisory Committee (PBAC) because of “uncertainty about the duration of effect and unfavourable cost-effectiveness.”
All hell broke loose and the first casualty was informed public debate. What followed was emotive, sensational lobbying and political opportunism, culminating in political interference from the highest level when the Prime Minister, John Howard, intervened and effectively vetoed the PBAC decision.
This “decision-making by media” has compromised the PBAC and potentially Australia’s drugs safety system.1
The lack of informed public debate has made decision making difficult on a personal level. Many parents will be wondering whether to recommend the vaccine to their daughters. Given that the vaccine is targeted at young teenage girls, there is an issue of informed consent. Next month the school immunisation program commences and consent forms will be sent home. How are parents meant to make an informed decision on behalf of their daughters? Just how effective and safe is this vaccine?
Because of the DES experience, I’m most interested in looking at drug safety. A concerning aspect of the debate on Gardasil is the lack of information on its safety, particularly long-term safety.
In the media, any mention of ‘safety’ is in fact talking about ‘efficacy’ – i.e. will the vaccine work for a lifetime, or is a booster necessary? Worryingly, in the government “fact sheet” for health providers, there are only 2 sentences relating to ‘safety’:
“Gardasil is generally well tolerated, with a small increase in reports of injection site reactions and fever compared to aluminium containing placebo (injection site reactions 83% vs 73%, fever 13% vs 11%). Very few serious adverse reactions were reported in clinical trials.” 2
There is no information on how long the clinical trials went for, and whether any large-scale trials were conducted on 12-13 year old girls.
Given that there is going to be wide-scale immunisation of thousands of young girls starting next month, the health authorities better be very sure there will be no unforeseen, unexpected side effects in the future. It would be truly tragic if the young girls receiving the vaccine faced an increased risk of, for example, infertility or autoimmune disease in 5, 10 or 20 years hence.
Hopefully animal modelling studies have been done to rule out this possibly.
1. Gina McColl: ‘Health care’s sticking point’, The Sunday Age, News Extra 12, February 25, 2007
2. Fact Sheet ‘Human papillomavirus vaccines for Australians: Information for GPs and immunisation providers’, National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, page 4, September 2006
From DESPATCH #54, March 2007, page 1
At the time of writing this my 2 daughters were aged in their early 20s and therefore not part of this school vaccination program. I might have mentioned in passing that I thought they didn’t need Gardasil, but I didn’t make a big deal of it.
What I didn’t realise was that the “hard sell” had been extended and was directly targeting all young women. During 2007 every time my daughters went to the doctor for some other reason, they were urged (one could almost say harassed) to have their Gardasil shots. They each received letters from various medical centres they had attended in recent years. These letters were sent out to all “eligible” young women urging them to have Gardasil while it was free. [I only found this out later as my daughters were not living at home but sharing a unit a couple of suburbs away.]
My younger daughter, aged 24 years, had the first 2 shots of Gardasil in late 2007. In March-April 2008 she had to take a number of sick days off work due to extreme tiredness and lethargy. She had a test for glandular fever (it was negative) and upped her intake of vitamins. Luckily she didn’t get around to having her 3rd shot of Gardasil and, after seeing what happened to her sister, she gives a serve to any doctor who suggests it!
My elder daughter Zoe was fit and healthy in May 2008 when she passed a thorough medical examination. Two months later – and one month after receiving the 3rd Gardasil injection – she was a housebound invalid: she couldn’t walk, drive or work.
I bought her a “health diary” and she recorded her symptoms, what she ate and what medication she was on. Looking back over this diary I don’t know how we got through those following weeks. I’m just so impressed with Zoe’s strength of character.
Her symptoms started off with a terrible rash (urticaria) which she had every day for 7 months. Her face would swell up (angioedma) so she looked like a boxer who had lost a fight. Her tongue had strange bald patches on it. She was having weekly blood tests. Initially these were normal but then her CRP levels (an indicator of inflammatory disease) were elevated and getting higher by the week. Her wrists and hands were swollen like severe rheumatoid arthritis. They ached and she had trouble holding things. Her knees and ankles were swollen and aching. The soles of her feet were so swollen she couldn’t walk and could only hobble short distances. There was inflammation of connective tissue and more tests were ordered looking for Lupus. By the end of July she started getting indigestion, gastric problems, severe abdominal pain and gastric reflux. She had 3 episodes where her throat swelled up and she had trouble breathing. In early September, while being examined by a Rheumatologist, a suspected heart murmur was picked up and she was sent for more tests. When she’d had the medical 4 months previously in May there was no heart murmur present.
Any one of these symptoms is painful and difficult to deal with. To have them occur suddenly, all at once, and with increasing severity was distressing and very frightening -particularly when the treatment (high doses of antihistamines) wasn’t working.
During this time Zoe’s younger sister was put under enormous stress as she had the responsibility of looking after Zoe on a day to day basis.
A breakthrough, in terms of understanding what was going on, came mid- August when we were given information on Ketotifen, a mast cell stabiliser. Apparently people with chronic urticaria and angioedma do not suffer from specific allergies, but rather an unstable mast cell system. According to the fact sheet, the unstable mast cells leak histamine, prostaglandins and leucotrienes, which result in other associated symptoms. For example, due to the release of these chemicals, patients also suffer from headaches, tiredness, lethargy, irritability and difficulty in concentration. It can also affect the gastro-intestinal tract causing cramping, bloating, indigestion, regurgitation, flatulence, intermittent diarrhoea and constipation. Many patients suffer from joint pains and muscle pain. These symptoms are due to the inflammatory properties of leaked histamines, prostaglandins and leucotrienes.
As the Clinical Immunologist we saw in October explained, unstable mast cells underlie autoimmune responses. So finally we had a diagnosis of Zoe’s condition that explained the symptoms – chronic uritcaria/angioedma, an autoimmune response due to an unstable mast cell system.
Having a diagnosis was only the beginning of the journey. Doing a rush job on reading up on the immune system and autoimmune disease left my head spinning.
Quite by chance the ABC TV program ‘Catalyst’ ran a special on ‘The Immune System’, 7 August 2008. The gist of the program was that our immune systems are fantastically complex, responsive and adaptive. Science is only now starting to unravel the wonders and complexity of the immune system.
Even more complex is the autoimmune response: this is when the body’s immune system defences turn back on itself and start attacking healthy cells and tissues. Autoimmune diseases include asthma, rheumatoid arthritis, irritable bowel, motor neurone disease, multiple sclerosis. What triggers this autoimmune response is unknown. Why some people get it and others don’t isn’t understood.
That’s why I get so angry when I think about Gardasil. Here we have a vaccine which deliberately meddles with the individual’s immune system. It is a new type of vaccine never used before. It uses new technology – recombinant DNA technology (which is like cloning) – to trick the immune system and artificially rev it up. No thought of triggering an autoimmune response, all they look for are injection site redness and fever within 24 hours. How dare they! Talk about irresponsible cowboys. Boys with their toys!
I think the diverse and varied adverse reactions to Gardasil may be immune responses. Our immune systems have evolved over eons. We are programmed with primitive survival reactions. Everyone has heard of the “fight or flight” reaction. However it appears there may be a 3rd primitive programmed reaction: “freeze”. When studying humans under extreme duress, researchers have found that people often become lethargic, they freeze up, shut down, becoming limp and still. This may be a primitive survival response – playing dead may discourage a predator from attacking. [Refer to ‘The Unthinkable: Who Survives Disasters – And Why’ (2008) by Amanda Ripley]
So maybe the many reports of girls fainting or experiencing temporary paralysis can be explained as an immune response – a response to the assault on the immune system by Gardasil.
It’s time to start asking questions of the drug manufacturers and the drug safety authorities. Specifically, exactly what studies were done prior to its release to show Gardasil is safe, that it doesn’t trigger immune/autoimmune responses? Where is the evidence of its safety?
Marian Vickers, Convenor DES Action Australia