Australia: BigPharma and Government maintain HPV vaccine safety even as casualties continue to mount Print E-mail
 Tuesday, 30 June 2009

Gardasil: the denial continues

By Renate Klein

Two weeks after receiving the “cervical cancer” vaccination Gardasil, 26-year-old Shannon from Melbourne remembers, “it became so difficult to breathe that I went straight to the emergency room. I was very frightened at this point. Two weeks before I had been fit and healthy, and by this stage I was limping around the house like a stroke victim, wheezing and worried I was suffocating.”

At the hospital Shannon had x-rays, blood tests and an MRI. She was told that the lining of her left lung had become so inflamed that it was rubbing against her chest wall each time she breathed. The Head Consultant looking after her said that she must have gotten some mysterious virus and that Gardasil had been tested and was safe. She was released with no diagnosis other than “pleurisy” and given painkillers.

Five months after receiving the vaccine she saw a neurologist who confirmed that she had damage to her left side and that it was “an auto-immune reaction, resulting in inflamed lining of the left lung and nerves on the left side, with a temporal connection to Gardasil injection”.

Shannon says she’s never been so sick all her life. Fourteen months later she had to quit her job and is now desperately trying to regain her health.

Jade, a healthy 15-year-old girl from Adelaide spent six weeks in hospital after the first Gardasil injection because of severe lower back pain and paralysis of the legs. She was advised to get the second Gardasil injection and “within two hours she had paralysis of the legs again. They just gave out on her while she was walking along.” Twelve months later, Jade almost drowned, her leg paralysis recurs regularly and she was re-admitted to hospital. She is in excruciating pain and the daily physiotherapy makes it worse. Morphine helps her sleep for a few hours but then the pain starts again. Her relatives are beside themselves with worry. And as they say “not one medical person would say that Gardasil was responsible for her condition. The moment you mention it, they all clam up.” Despite an MRI no one has a diagnosis.

Shannon and Jade are just two of the Australian girls and women who have become seriously sick after receiving one or all three shots of the “cervical cancer” vaccine Gardasil free of charge, care of the Australian Government. Their upsetting stories and many others can be read here.

The free vaccinations for girls aged 12-13 and women up to 26 were started in April 2007. Gardasil is a vaccine against four strains of the sexually transmitted infection with human papillomavirus (HPV), two of which are associated with the development of cervical cancer. There are more than 100 strains of HPV and we are told that up to 80 per cent of people acquire the virus at some point in their lives. The good news is that in 90 per cent of these, a healthy immune system causes the virus infection to disappear in one to two years and no abnormal cells, let alone cancer, will ever develop (Lippman et al., 2007).

Moreover, as Merck-and GlaxoSmithKline-funded Rachel Skinner and colleagues write, “Estimates of the prevalence of HPV infection among women range from 2% to 44%, depending on age” ( Skinner et al., Medical Journal of Australia, Vol. 188, number 4, February 18, 2008). Such figures are much less scary than the widely quoted “80 percent infected” (both women and men). Even more confusing is the fact that HPV infection, usually classified as a sexually transmitted infection (STI), can already be found in new born babies even if their mothers do not carry the HPV virus (Xavier Castellsague and colleagues, 2009 “Human Papillomavirus (HPV) infection in pregnant women and mother-to-child transmission of genital HPV genotypes: a prospective study in Spain” BMC Infectious Diseases, 9:74).

There is a lot more to learn about the HPV virus than the simple story of a “cancer virus” annihilated by a miracle vaccine that the proponents of Gardasil want us to believe.

Furthermore, deaths from cervical cancer in Australia are continuing to decline probably due to a mixture of regular screening, improved general health and sexual hygiene. According to a report by the World Health Organisation, in 2006, 249 women died in Australia, and cervical cancer mortality ranks 17 out of all 23 listed cancers ( WHO/ICO, 2007, p8). While every death is a tragedy, pre-cancerous cells are being detected through systematic Pap screening programs. Indeed, Gardasil advocates caution that women must continue with the Pap Smears as the vaccine will not be 100 per cent protective. For all these reasons, the question really must be asked how the need for this costly vaccine can be justified?

Australia was the first country to rush into administering this new and experimental vaccine on a grand scale. Straight after the first vaccinations reports about serious adverse effects began to surface (“ Gardasil: we must not ignore the risks” Renate Klein and Melinda Tankard Reist, June 1, 2007 and “The Gardasil 'miracle' coming undone?” Renate Klein, August 21, 2008.)

Commonwealth Serum Laboratories (CSL) and Merck - the manufacturers of Gardasil - deny that there are any problems. So does the Therapeutic Goods Administration (TGA). They continue their assessment of “Gardasil as safe and effective”. Their latest communiqué of May 5, 2009 states that “As of April 2009 a total of 1,304 suspected adverse reactions have been reported …” but that “The great majority have been mild and common problems such as soreness, swelling, or redness of the injection site”.

These “mild problems” are a far cry from Shannon’s and Jade’s serious illnesses or from Julie’s experience of grand mal seizures and the woes of Philippa who continues to suffer from pancreatitis - all developed after the Gardasil injections.

In the USA by May 2009 more than 16,000 adverse reactions were reported (these figures represent only between 1 and 10 per cent of all adverse reactions) and 47 deaths have been associated with Gardasil: four times the number of deaths associated with Menactra (a vaccine against meningococcal).

The Gardasil manufacturers maintain that these deaths are not directly linked to the vaccines. With respect to the deaths of healthy US teenagers from cardiac problems the suggestion has been made that these girls might have suffered from a pre-existing undiagnosed weakness (for example, a heart murmur). For the tragic testimonial of a heartbroken mother who lost her child, see here:

Gardasil is not recommended for pregnant women but there have been reports of spontaneous abortions and fetal abnormalities when pregnant women were inadvertently injected with Gardasil during the Merck trials. Merck is sufficiently concerned that it has set up a registry to follow pregnant women who have received Gardasil. It is unknown if Gardasil will affect fertility.

While the promoters of Gardasil continue to assert that these health concerns are unwarranted and that their vaccine will greatly reduce the incidence of cervical cancer, such claims are far from uncontested. In November 2008, 13 scientists from Germany’s Bielefeld University challenged the STIKO (the equivalent of the TGA) to reconsider their endorsement of Gardasil for health insurance reimbursement. Their main point is that results from the manufacturer-sponsored research trials resulted in only 17 per cent reduction of cervical lesions - nothing like the 98 per cent of reductions Merck is claiming.

In April and May 2009 in the UK and Scotland, groups of parents have started to sue GlaxoSmithKline, the manufacturer of the “sibling” vaccine Cervarix (from which CSL also gains royalties) for seriously injuring their children. In New Zealand, up to 80 schools are refusing to implement the HPV vaccinations. Even one of the scientists involved in the Merck research of Gardasil, Diane Harper, has since 2007 called it a “great public health experiment” and voices long-term concerns about safety and effectiveness, especially when girls as young as 11 are vaccinated. As she put it, “We don't know the vaccine will continue to be effective. To be honest, we don't have efficacy data in these young girls right now.” (“ Vaccination campaign funded by drug firm”, Sarah Boseley, March 26, 2007). Two years later, the situation hasn’t changed: fewer than 1,200 girls under 15 have ever been in Gardasil trials. And yet millions of 12-13 year old girls have already received the three shots.

On June 9, 2009, the US Food and Drug Administration (FDA) approved a new label for Gardasil which now includes fainting (syncope) and seizures in its Warnings and Precautions. And, crucially, in Australia ordinary citizens are beginning to be critical of the HPV vaccination - quite simply because more and more personally know injured girls and young women or hear about them from friends or teachers.

But the Australian government remains silent and thereby continues its denial about problems with Gardasil. The TGA hasn’t even issued a new communiqué that details the June FDA warnings. It is high time that the Federal Health Minister, Nicola Roxon, showed leadership. Today, June 30, 2009, brings the end of free vaccinations for women up to age 26: a good time to suspend all Gardasil vaccinations (those for schoolgirls included) and check the health status of every single woman and girl who was vaccinated with Gardasil since April 2007. This should be done with the help of the belatedly implemented HPV Register. Such a serious investigation will show the world that Australia cares about the health of its young female population and will hopefully give the victims of Gardasil the rightful acknowledgment and care that so far has been sorely lacking.

About the Author

Dr Renate Klein, a biologist and social scientist, is a long-term health researcher and has written extensively on reproductive technologies and feminist theory. She is a former associate professor in Women's Studies at Deakin University in Melbourne, a founder of FINRRAGE (Feminist International Network of Resistance to Reproductive and Genetic Engineering) and an Advisory Board Member of Hands Off Our Ovaries.