Girls and Gardasil: the protection game

Imagine this. You are the parent of an eleven year old daughter. Early in the school year you receive a consent form for the standard Year 7 immunisations: Hepatitis B, Diphtheria-Tetanus-Pertussis, Chickenpox and Human Papillomavirus (HPV). Do you just tick all the boxes, or do you spend time considering the implications of your decision?

The last one on the list deserves special attention. HPV is a sexually transmitted infection, a point that the consent form neglects to mention. It merely states, “HPV is the name for a group of viruses that cause skin warts, genital warts and some cancers.” The arguments for and against this particular immunisation are rarely provided by schools, yet parents, for the sake of their children, need to consider carefully the messages they are conveying by agreeing to this vaccine.

Not just a generalised childhood disease

Most people would agree to vaccinating their children against infections that are generalised within the community so that everyone stands an equal chance of catching them – whooping cough and measles, for instance. But there is a new class of diseases that are increasingly being targeted by vaccine developers: sexually transmitted diseases such as Hepatitis B and cervical cancer, and this is where parents need to consider more carefully whether to immunise or not.

In the case of Hepatitis B there is an argument for immunising your child as the disease can be spread not only sexually, but also (rarely) through blood transfusions or blood-to-blood contact, for instance through sports injuries. Cervical cancer, however, is contracted exclusively through sexual activity. Like HIV, oncogenic HPV could not spread through the population if people were strictly monogamous.

Undermining the chastity message

The argument advanced for vaccinating schoolchildren is that most will be sexually active by the time they are eighteen and will have caught the virus by their early twenties; therefore, to be effective, the vaccine has to be administered prior to sexual debut. While this may appeal to parents with a pragmatic approach to life’s challenges, parents who are looking at the overall formation of their children need to take other factors into consideration. They have probably already had conversations with their children about the importance of exercising sexual responsibility prior to marriage and, with luck, they have been demonstrating steadfast fidelity and mutual support in their own marriage.

Deciding that they need to vaccinate a daughter against a sexually transmitted disease seems like a vote of no confidence in the child’s ability to display sexual self-control or choose a like-minded husband. It is like saying to a child, “Eat healthy foods, don’t overindulge and you won’t become obese … but, just in case you can’t control yourself, we’ll give you gastric banding surgery in advance.” Child psychologists are agreed that children are good at spotting when parents give them contradictory messages – and may later use them as justification for their behaviour. A school-based programme adds a social message that early sexual intercourse is allowed, as long as one uses “protection”.

Some parents defend their decision to allow their child to be vaccinated with the argument that the daughter may marry a partner who is unfaithful or who is deciding to settle down after years of sexual freedom and may transmit the virus to his wife, who becomes the innocent victim. Or the daughter may indulge in risky behaviour prior to marriage. While these scenarios are certainly possible, it again assumes a certain casualness about relationships.

The question we should be asking is, do we base our family decisions on worst case scenarios or do we try to support our children by building a “best practice” ethos within the family? And, importantly, using worst case scenarios to justify vaccination against STDs does not take into account the other ways of preventing cervical cancer nor the possible side-effects of vaccination.

What is the real motivation behind this vaccine?

Promoters of Gardasil like to portray themselves as crusaders against a killer disease. Is there more to it than that? If you look at the history of HPV vaccine development, you find that the immunologist Ian Frazer started out by investigating Hepatitis B -- another sexually transmitted disease - in homosexual men. Finding that there was a high incidence of genital warts among this group led him to look at the cause: HPV. So the original intention had nothing to do with preventing cervical cancer in women; it had more to do with preventing genital warts in homosexual men.

If governments wanted to address the causes of HPV infection, they would spend more on programmes to reduce the high-risk behaviour that spreads the disease. But in a society where there is no-fault divorce and sexual experimentation at a young age is regarded as the norm, any government that tried to educate its young people about the links between sexual freedoms and STDs would be accused of moralising.

Between 2006 and 2010, the Australian Government will spend $436 million on providing HPV vaccination free to girls and young women. The fact that this sort of money is being spent without any accompanying education about sexual responsibility demonstrates that the motive is to provide validation for a society which believes in consequence-free sexual liberation. This is hardly a prudent allocation of health care resources.

Be cautious when the authorities are economical with the facts.

In the state of Western Australia, the Health Department consent form for Gardasil makes no mention of the fact that, despite having the vaccination, the child will need to have biennial pap smears as an adult. This is because Gardasil targets only two out of 15 oncogenic, or cancer-causing, types of HPV. Admittedly, the two types, HPV-16 and HPV-18, are responsible for about 70 per cent of cervical cancers, but the problem is that having the vaccination can give a woman a false sense of security.

On the other hand, pap smears are already very effective at preventing deaths from cervical cancer, which have been steadily decreasing in Australia since population screening was introduced in 1991. In 2002 there were more deaths from murder in this country than from cervical cancer.

Unintended consequences

Some researchers have suggested that the vaccine may cause changes in the ecology of the cervix, so that other HPV strains increase when the four that Gardasil targets are reduced. In an editorial in the Journal of the American Medical Association, Dr Charlotte Haug asks: “How will the vaccine affect other oncogenic strains of HPV? If HPV-16 and HPV-18 are effectively suppressed, will there be selective pressure on the remaining strains of HPV? Other strains may emerge as significant oncogenic serotypes.” The answers to these sorts of questions will only be known after many years.

How likely is cervical cancer anyway?

Promoters of the vaccine have inflated the likelihood of developing cervical cancer. This was particularly obvious when, in 2006, Janette Howard, wife of the then prime minister of Australia, spoke out about having battled cervical cancer ten years earlier. The line was frequently heard, “It could happen to anyone.”

But the risk factors are not equal for everyone. Although an average of 79 per cent of the female population is infected with genital HPV at some point in their lifetime, only a small proportion of those go on to develop cervical cancer. Most infections are dealt with by the immune system and do not progress, and those that do progress tend to be linked with the effects of smoking, oral contraceptives, irregular screening, living in rural and remote areas, and repeat infections caused by multiple sexual partners. Cell damage caused by the virus is slow to develop and cancers can take 10 to 40 years to appear. Where 2720 people died of breast cancer in 2003, only 237 died of cervical cancer -- a number that had dropped by 41 per cent since 1993.

Which is worse: side effects now or future avoidable death?

The actual death rate from cervical cancer in Australia is 2.4 per 100,000. To assess the risks versus the benefits of the vaccine we need to compare this rate with the rate of serious side effects of the vaccine.

Much has been made in the popular media about the trivial nature of side effects – “Gardasil’s top side effect is fainting,” announced one news headline. But if we look at the actual side effects measured in the US postlicensure surveillance study by Barbara Slade and her team, we find that for the 23 million doses distributed in America, there were 772 serious adverse events. That’s a rate of about 3.4 per 100,000 doses. Typical among them were anaphylactic reaction, venous thromboembolic events (i.e. blood clots), Guillain-Barre Syndrome (an autoimmune disease causing paralysis), transverse myelitis (inflammation of the spinal cord causing paralysis), pancreatitis, convulsion, motor neuron disease and death.

Taking into account that each recipient normally receives three doses of vaccine, the rate jumps to 10.2 per 100 000 of population. Dr Slade herself admits that “the significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system” – meaning that, because the measurement of side effects was based on voluntary reporting by the public, the real figures are probably higher. So the risk of a serious adverse event as a result of the vaccine is at least four times higher than the risk of dying of cervical cancer without the vaccine.

Parents need to judge whether the risk of a child suffering serious side effects is less important than the avoidance of a hypothetical and preventable future cervical cancer death.

Unknown longevity

The Future II study group – a group funded by Merck to investigate the HPV vaccine – emphasized as a conclusion of their 2007 phase III trial of the vaccine that “durability of vaccine-induced protection beyond five years is unknown”. Dr Diane Harper, one of the researchers paid by Merck to design and carry out clinical trials for Gardasil, observed in an interview with Sharyl Attkisson on CBS News: “If we vaccinate 11-year-olds and the protection doesn’t last … we’ve put them at harm from side effects, small but real, for no benefit. The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70 per cent of all sexually active females of all ages are vaccinated.”

Some vaccines are more equal than others

We have reason to be wary when we see some vaccines bypassing hurdles that would normally be compulsory. Dr Haug notes: “The first HPV vaccine was licensed for use in the United States in June 2006, and the Advisory Committee on Immunization Practices recommended routine vaccination of girls aged 11 to 12 years later that same month. However, the first phase 3 trials of the HPV vaccine with clinically relevant end points – cervical intraepithelial neoplasias grades 2 and 3 (CIN2/3) - were not reported until May 2007.”

Australia followed the US lead, and by 16 June 2006, the Therapeutic Goods Administration had approved Gardasil for females aged 9 to 26 years and males aged 9 to 15 years, this despite the fact that the Data and Safety Monitoring Board had not yet reached their conclusions for two of the corroborating clinical trials.

Do financial motives affect clinical recommendations?

Drs Sheila and David Rothman of Columbia College of Physicians and Surgeons have described how in 2006, Gardasil was named the pharmaceutical brand of the year for “building a market out of thin air”. Merck had learned from its sales of the Hepatitis B vaccine not to define the target population in terms of high risk groups, but to “promote it for all women, and secure government reimbursement and mandates.” At the same time, Merck was planning for a 2008 commencement of compensation payments to victims of their Vioxx anti-inflammatory arthritis drug which had caused thousands of heart attacks and deaths, and needed to correct their balance sheet.

To win over health professionals, legislators and the general public, Merck funded a number of established American professional medical associations to run educational campaigns to promote the Gardasil vaccine. In Australia, the Merck and CSL-funded Professor Ian Fraser was given the title “God’s Gift to Women” by the Weekend Australian and went on to receive the 2006 Australian of the Year award, all of which could not have failed to enhance the vaccine’s acceptability.

A recent Merrill Lynch report predicts Merck’s sales of Gardasil will reach US$2.7 billion by 2011. In Australia, CSL announced $185 million in Gardasil sales in Australia and New Zealand for the year ending June 2009 as well as $161 million in HPV vaccine royalties. As Dr Haug sums it up, “Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians…the balance is easily skewed.”

To conclude. Parents need to consider two main strands in their decision making: firstly, the philosophy underpinning their consent to an STD vaccine, and secondly, the medical facts concerning this vaccination and possible side effects. Our children deserve no less.

Deirdre Fleming is a former Science Teacher, currently pursuing postgraduate studies in Public Health at Curtin University, Perth, Australia.


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