The Gardasil 'miracle' coming undone?

The Therapeutic Goods Administration (TGA) has announced that it is investigating whether there is a link between Gardasil, the vaccine against the human papilloma virus (HPV) and the development of pancreatitis in three young women as reported in a letter to the Medical Journal of Australia (Louise Hall in Sydney Morning Herald, August 17, 2008 referring to Das et al., MJA 189(3), August 4).

This investigation is good news - but not one minute too early. While the TGA are doing this work, they should also look in detail at the other adverse effects that have been reported in Australia and around the world. And it’s not just “headaches, redness at the injection site, nausea and vomiting” as the TGA claims (ABC News, August 17, 2008).

There are many serious reports including seizures, debilitating tiredness, body rashes, serious walking problems, severe menstrual pain and irregularities, chest pain, anaphylactic reactions. And these symptoms can persist for weeks, sometimes months. (See our blog which we started so that girls and women would have a space to tell their stories, as well as to make available critical background reading.)

Then there is Guillain Barré Syndrome (paralysis), Acute Demyelinating Encephalomyelitis (ADEM, a neurological disorder characterised by inflammation of the brain), miscarriages and fetal abnormalities in women who were mistakenly administered the vaccine while pregnant.

Not to mention the 17-20 deaths that have been associated with the vaccine in the USA (reported to the federal Vaccine Adverse Events Reporting System, VAERS) as well as one death in Germany and one in Austria. Like Jessica Ericzon, a 17-year-old student who was a softball player but collapsed and died two days after receiving the second Gardasil shot (Susan Edelmann, The New York Post, July 20, 2008).

Or 14-year-old Jenny and her sad story of rapidly deteriorating motor neurone disease following the Gardasil injection. Her family is desperately seeking “comparables”, other girls with similar conditions, whose treatment might help save their severely ill daughter.

Australia may just be lucky that no deaths associated with Gardasil injections have occurred (or been reported?). But the luck might run out any moment, so the vaccination program needs to be suspended now. The precautionary principle should be used whenever the health and lives of young girls and women are at stake.

So far the TGA as well as the FDA (US Food and Drug Administration) have denied any association between the deaths or serious health problems and Gardasil. And already insinuations abound, “… might have been a genetic disposition”; “might have been an pre-existing heart murmur”. So it was all the girls’ “fault”, nothing to do with the vaccine!

In January 2008, Channel 7 analysed TGA data from a FOI request which showed 681 adverse reactions with 162 girls and women not recovered. Girls between 14 and 17 had not recovered for an average of 165 days. On July 4, 2008, the TGA published new figures of just over 1,000 adverse reactions to-date that had been reported. But they did not release in depth details of what these reactions were and, importantly, whether or not the girls and women had recovered.

Reporting is not mandatory in Australia (or the USA) and it is well known that only between 1 per cent and 10 per cent of adverse reactions are ever reported. So we are looking at much higher figures - especially as many doctors dismiss girls and women’s health complaints after the injections as unrelated to the vaccine. In the USA, by June 30, 2008, the reported figure had grown to 9,749 adverse effects.

We have been told that more than 3 million doses of Gardasil have been distributed in Australia. That’s about a million girls and young women who received the three Gardasil injections since the free vaccination began to be rolled out on April 2, 2007 for 12- to 18-year-olds in schools and at GP surgeries for 16- to 26-year-old girls and women. Now every single one of them needs to be contacted and asked about the state of their health since the three injections. General lethargy and tiredness as well as menstrual problems have to be included in the questions as they might be indications of auto immune problems. And if the girls and women are still unwell, free treatment should be offered.

To find them all will be a tedious job but this is the government’s own fault. It was only on February 23-24, 2008 that the Victorian Cytology Service ran a job advertisement for a “newly created position” to “help establish and operate the new National HPV Vaccination Program” (The Australian, 23-24 February 2008). That’s 11 months after thousands of school girls had already received the jab.

It is quite scandalous that Australia rushed so breathlessly into the world’s first free vaccination program without also simultaneously establishing a Vaccine Registry in which every vaccination recipient would be included and could easily be tracked if any problems emerged or to establish the remaining level of antibodies. Now they have to do it the hard way and shortcuts must not be allowed to occur.

But why this rush to use Australian girls and young women as guinea pigs for this new vaccine? What is the appeal of Gardasil? There is no epidemic of cervical cancer in developed countries. In Australia, about 200 women a year die from it - approximately two per 100,000 - and while every death is one death too many, the numbers have been going down from year to year due to Australia’s screening program.

At least three main reasons account for the vaccine hype.

One, the word “cancer” triggers an incredible fear reaction in most people.

Two, great marketing of the vaccine which, in Australia, is mixed with a good dose of patriotism. We are told that Queensland scientist, Professor Ian Frazer, with his Chinese colleague was the “inventor” of the HPV vaccine. This has made him into a national hero and the Australian of the Year 2006. Frazer: “God’s Gift to Women” proclaimed the cover of The Weekend Australian’s magazine on March 4-5, 2006. In actuality, like Ian Frazer at Queensland University, US Universities of Georgetown and Rochester and the US National Cancer Institute (NCI) all claim “… to be responsible, for original work leading to a cervical cancer vaccine” (see Ruth Beran, July 21, 2006). Is acknowledging others that hard?

In Australia, critics are almost perceived as national traitors and unlike in Germany, Canada and Spain, very few critical voices have been heard in the public debate (www.harald-terpe.de/2637.98.htm June 17, 2008; Lippman et al. CMAJ, August 2007; Juan Gérvas, Rev Port Clin Geral 2007 23, 647-55, accessed here).

In the USA, one of the scientists who worked on the Gardasil trials sponsored by Merck, Professor Diane Harper of Dartmouth Medical School, has been urging caution for some time. “It's not a cure-all for cervical cancers and it's not meant to be a replacement for Pap tests’ she said (Danielle Egan, May 31, 2007 The Tyee, Vancouver, Canada).

The third reason can be found in media reports which too often unquestioningly repeat what is fed to them by vaccine advocates. The fact is that HPV as well as cervical cancer are complicated and messy scientific phenomena with lots of question marks remaining. This complexity is difficult to explain. So the over enthusiastic media message gets simplified to “Gardasil Prevents 70 per cent of Cervical Cancer”. And parents who want to do the responsible thing sign their daughters up for vaccination.

But no one knows if Gardasil will ever prevent a single case of cervical cancer. There is certainly no proof to date because cervical cancer can take 20 to 30 years to develop and research into the HPV vaccine has only taken place for the past five years. What manufacturer-sponsored researchers have claimed as success was seeing fewer benign lesions develop in research participants.

Of course it would be highly unethical not to treat women who develop such abnormal cells in either the vaccine or the control group. And therefore we might never know whether the vaccine really worked or whether perhaps the new “Thin Prep” (PDF 96KB) adjunctive to Pap Smears might be the reason for a higher and more reliable detection rate that further reduces deaths from cervical cancer.

HPV strains appear to be present in 80 to 90 per cent of both women and men (another estimate as no one really knows), but clear up within one to two years. Co-factors that stop the body from naturally clearing abnormal cells are smoking, poverty, a poorly functioning immune system, bad nutrition, use of the oral contraceptive, unsafe sex, multiple sexual partners and a lack of male sexual hygiene (circumcised men have fewer HPV infections; see Zukerman in The Weekend Australian, August 16-17).

On top of all of this, if the vaccination program had indeed been aimed at reducing HPV infection in the general population (i.e. create “herd” immunity), boys should have been included from the very beginning. That they were not, shows once more that it is always women - and now even girls - who bear the burden of dangerous drugs for prevention whether it’s an unplanned pregnancy or an HPV infection. No shared responsibilities here!

In fact there is even still disagreement if HPV, a sexually transmitted virus, is at all implicated in cervical cancer. In at least 30 per cent of such cancers this virus is not found. So screening must never be stopped; no HPV vaccine will protect these women. A “quick fix” technology won’t work.

It’s also unclear if HPV “causes” the cancer or, rather, is “associated” with it (e.g. already existing cancer cells might spread more rapidly if HPV is present). Most importantly, there are an estimated 20-40 HPV strains that infect the female genital tract and of those Gardasil covers only two “high” risk strains (16 and 18) and also 6 and 11 which can lead to genital warts. The great worry is that even if strains 16 and 18 were neutralised by the vaccine, other virus strains might become more active.

This is a very important point because it appears that most infections are “mixed”, that is they consist of a number of HPV strains (see “HPV Vaccination - More Answers, More Questions” by George F. Sawaya, M.D., and Karen Smith-McCune, M.D., Ph.D. in the New England Journal of Medicine 356:1991-1993).

We also don’t know if the vaccine-produced immunity will last, nor if and when booster shots might be needed. Further, there are fears that an immunity created early in life might allow for more virulent reactions in later years. And Gardasil is a genetically engineered vaccine; it also contains a high amount of aluminium adjuvant which is known to be responsible for very serious reactions in other vaccinations.

With all these unanswered questions, the worrying rise of serious adverse effects, the lack of independent research, parents of girls and young women themselves should seriously consider if the vaccine is worth the risk.

Let’s not forget that Gardasil was fast tracked through the FDA, a process normally reserved for life saving drugs. And that, amazingly, it received the green light in 2006 for girls as young as nine despite the fact that fewer than 1,200 girls under 16 had taken part in the manufacturer-sponsored research. And that some trials weren’t even finished.

Since then Gardasil has become the fastest selling drug to reach US$1 billion sales - cash much needed by Merck who has started this year to pay compensation to the Vioxx victims (a Cox2 anti-inflammation drug for arthritis that had resulted in thousands of heart attacks and deaths). And great for the Australian manufacturer, Commonwealth Serum Laboratories (CSL) which receives royalties from Merck from its overseas license of Gardasil. CSL reported a 30 per cent rise in full year profit (to June 30, 2008), and is so cashed up that it has recently entered a sales agreement for $3.48 billion for a plasma manufacturing company (AAP, August 13, 2008).

But surely girls’ and women’s health must never be compromised by monetary gains for shareholders. The Gardasil saga reminds me of Hormone Replacement Therapy (HRT) where for 40 years millions of women were told that this “miracle drug” would save them from a life of misery after menopause when, in fact, it increased the risk of breast cancer and heart attacks. Since 2002, when medical consensus finally dealt a blow to HRT, breast cancer rates have been falling both in Australia (in NSW by 6.7 per cent) and the USA (by 12 per cent) (Cathy O’Leary, The West Australian, June 2, 2008).

I hope we won’t have to wait 40 years for the Gardasil “miracle” to become undone.

It is time for Nicola Roxon, the Federal Health Minister, to step into this fray and listen to the girls and women for whom the vaccine has meant pain and debilitating illness. She must suspend the Gardasil vaccination program before it claims more victims and launch an thorough investigation into the health of vaccine recipients.

We need her strong leadership now.