I noticed today a front-page article from Wednesday’s edition of The Metro. The headline:

Gardasil

Jab that beats cervical cancer

A ‘wonder drug’ to beat cervical cancer has proved almost 100 per cent successful in trials.
Gardasil blocked the two major strains of a virus which cause most cases of the disease, tests involving more than 12,000 women showed.
The results prompted health campaigners to call on the Government to make the vaccine readily available for girls in secondary schools.
However, critics have warned such a move will only encourage sexual promiscuity in the young.
In the latest research, women aged between 15 and 26, from 13 countries, were monitored for three years. The vaccine was 98 per cent successful in targeting two strains of the human papilloma virus and preventing pre-cancerous changes which can lead to the disease.
In nine out of ten women, it also blocked two other strains of the virus which cause genital warts.
US researcher Dr Kevin Ault said: ‘Severe reactions to the vaccine appear to be rare.’
His team’s findings confirm those of Australian researchers who tested more than 5,450 women.
Writing in the New England Journal Of Medicine, two experts said: ‘Investigators in these trials have hit their mark soundly.’
Gardasil was approved for females aged nine to 26 by the EU in September but is available only privately in Britain. The jabs are most effective when given before a girl becomes sexually active.
Cervical cancer charity Jo’s Trust wants a nationwide programme of vaccination in secondary schools launched by the end of the year.
‘This new data is a significant breakthrough,’ it said.

A person reading this report could be forgiven for thinking that a miracle is upon us. Let us all go forth and vaccinate! But it aint necessarily so.

Some Gardasil facts:

  • According to the studies done so far, Gardasil is very effective against two strains of HPV which can cause cancer. It has no effect on the other 13 strains of HPV which can lead to cancer. These strains cause around 30% of current cervical cancer cases.
  • Gardasil only works if you are not currently carrying any of the targeted strains around with you. Since HPV infection rates are high (most of us will get infected with at least one strain at some point in our lives), there are going to be a lot of people for whom this vaccine just doesn’t work.
  • Since HPV infection rates are especially high among young people in their mid to late teens, when they start to have more of the sort of skin-to-skin physical contact with each other (NOT necessarily sex) that can transmit the virus, it would make sense to catch them before they reach that age. That is why the jabs are most effective before a person becomes sexually active. This would mean vaccinating girls who are pre-pubescent, let’s say at around the age of 11 or 12. The research so far on girls under the age of 16 has involved 506 girls. I do not know how many of them were aged 11 or 12, which is the age we are talking about giving this vaccine, but I suspect it is a relatively small proportion because of the ethical problems involved, which must increase as the subject is younger and more vulnerable. The drug is actually licensed for girls as young as 9 and NONE of the research subjects were younger than 10. What all this means is that we do not know whether the vaccine works for younger girls and we do not know whether it is safe for younger girls.
  • The research done so far has taken place over a total period of around 11 years, with each study lasting no more than about 3 years. One consequence of this is that the study period was not long enough for cervical cancer to develop in any of the subjects, so that Gardasil’s “effectiveness” as established in those studies relates not to the prevention of cancer but to the prevention of cervical precancerous lesions – it may be highly likely that preventing the HPV-related lesions will prevent the cancers, but the studies did not in fact test this because they were cut short.
  • Nobody has undertaken any research on how long the protection might last or whether a booster might be needed. No booster has been developed or approved. This gives rise to some questions. What if protection only lasts for, say, 5 to 10 years? Are girls to be vaccinated aged 11 and then find that their protection wears off by age 16 to 21, just when they need it the most because they are most likely to be getting off with loads of people? If a booster is needed, how long will it be before one is developed and approved? Will the booster arrive on time. If not, what then?
  • Adverse reactions rarely make the headlines but they do happen, as with all vaccines. Common reactions (i.e. more than 1%, and more likely to occur in the test group than the control group given a placebo) include: soreness at the vaccination site, swelling, erythema (redness or inflammation), fever, nausea, pruritis (itching), and dizziness. These reactions are described as “mild and moderate” by the FDA. Other, more serious reactions have occurred – and the sample sizes have been too small to identify whether there may be any really rare but actually life-threatening reactions.

Here’s something else to bear in mind. A lot of the “anti-HPV” sentiment you will see in the media focusses on the fear that little girls who are vaccinated against a sexually transmitted disease might decide they have a free pass to go out and be promiscuous and reckless. I’ve already commented on the stupidity of this objection in this old post. I think it’s also worth mentioning that this promiscuity objection is the only one you will normally see in media reports – perhaps it is juicier than the real problems with this vaccine. It is also the one that immediately springs to the average punter’s mind when reminded that the vaccination is “controversial” or “hotly debated”.

What are less often cited are objections based on public health concerns, which – you would think – are what we should actually care about and are what people who actually do care about women more than money are raising. Here are the main objections that I have come across, even excluding the concerns about this vaccine’s unproven safety and efficacy as noted above:

  • It is likely that many women having had a “cervical cancer jab” (as it is marketed – it is in fact an HPV jab) will not bother with smear tests. But smears will still be essential to detect the many cervical cancers that this vaccine will not prevent. And smears will still be essential in the long term in any event, given that we do not know how long the vaccine’s protection will last – would you trust a vaccine to protect you for life, when studies only followed their subjects for about 3 years? No, perhaps not – but many people would. The result could be that while we eliminate around 70% of cervical cancers for the (unknown) period of protection we suddenly find that instead, we end up failing to diagnose a lot of cancer that will still develop in time to treat them – either because they were cases not affected by the vaccine in the first place, or because the vaccine has worn off. The incidence of cervical cancer could even go up.
  • This vaccine is given by a course of three shots over a six month period. One of the reasons normally cited for insisting that children should be given MMR rather than single jabs has always been that if you have to undergo a course of three shots the chances of a child completing the course are very much reduced. That is going to be an even bigger problem if the vaccinations are to be given through schools – what if the child is off sick on the relevant day? – you can bet the nurse won’t be coming in specially, just to jab the stragglers. What will happen is that a significant number of children will run the risks of undergoing this vaccination without getting the benefit because they do not complete the course.
  • There will be another large chunk of the population who get the jab but do not get any protection because they already have the relevant HPV strain(s). They will think they are protected, but they are not. The only way to tell whether a girl or woman has the strain is to do a vaginal swab – are we going to do that for 11 year olds? I don’t think so.
  • This vaccination costs $360, roughly £200, for the course of three shots. Multiply that by, say, a million children per year, and add in the staff costs and other overheads involved in distributing and administering the vaccination. How far would that NHS money go towards the fight against other diseases – things like lung cancer and heart disease – which are much bigger killers of women than cervical cancer will ever be?
  • Most women and girls fight off the HPV vaccine using their natural defences. Far more are infected with HPV than ever develop precancerous lesions or cervical cancer. We just don’t know whether this vaccine might interfere with our natural protection, and we just don’t know what public health consequences might flow from that.
  • Boys get HPV too. Why are only girls being expected to take this vaccine? Boys get HPV with just as much frequency as girls do, if not more so. Boys and men can contract genital warts and cancers as a result of such infection – Are boys missing out on vital protection? Or are girls standing in as guinea pigs in a great big public health experiment? Are we, and our daughters, being vaccinated for the benefit of men?

I don’t pretend to know whether it is a good idea for a girl to have an HPV vaccine. It might be as safe and effective as we are told. The concerns expressed might be outweighed by the benefits. The point is – hardly anyone is talking about these questions; and NOBODY knows the answers.

Two heroes in the fight for truth and beauty are Diane Harper and her media ally Cindy Bevington. I urge you to read the following articles:

Researcher blasts HPV marketing – 14 March 2007
Researcher adds to vaccine comments – 21 March 2007
Legislators misguided about vaccine, researcher says – 21 March 2007
Medical journal sides with HPV scientist – 11 May 2007

I also urge you to read Grace Householder’s article detailing her interview with pro-Merck researcher Darron Brown: IU researcher claims Gardasil is “safest vaccine” – 11 April 2007 as well as an editorial which I suspect she also wrote: Ten reasons why HPV vaccine is “murky” issue – 4 February 2007.

Other sources:
FDA approval announcement – 8 June 2006
Medical News Today – 3 November 2006
eMaxHealth article – undated
How Stuff Works article – undated (warning – this article should be subtitled: “America’s Shut-the-Fuck-Up Guide to Medicine the Patriarchal Way”)

and, of course, Sparkle*Matrix – here and here.

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