Revealed: The serious health concerns about the cervical cancer jab
Isla Whitcroft, The Daily Mail
September 2, 2008
The pink leaflets are ready, the posters are poised to go up and the advertising slots have been booked both on kids and primetime TV and radio.
Tomorrow marks the start of a new academic year. It is also the launch date of a campaign which heralds the introduction of the biggest mass vaccination programme for more than a decade.
By the end of September, there will hardly be a Year Eight girl (aged 12-13) in the country who doesn’t know that, barring an opt-out, she is shortly to receive three injections of the drug Cervarix, which will offer her 70 per cent protection against cervical cancer.
Later in the year, another 300,000 girls aged 17 and 18 will be vaccinated before they leave school. By 2012, most girls over the age of 12 should have received the vaccine.
Made by pharmaceutical giant GlaxoSmith-Kline, Cervarix works by creating an immunity against the two strains of the human papillomavirus (HPV), numbers 16 and 18, responsible for 70 per cent of all cervical cancers.
For the Government, the programme – reputed to have cost tens of millions of pounds – has been seen as little short of a community medicine triumph.
‘This vaccine could save the lives of 400 women a year,’ pronounced public health minister Dawn Primarolo earlier this year, shortly after it was announced that GlaxoSmithKline had won the contract to supply the drug over its rival Merck, who make the more expensive vaccine, Gardasil.
‘It is an exciting opportunity to immunise young girls against the future risk of cancer, the impact of which will be felt by women and their families for generations to come,’ she said.
And, on the face of it, who could argue? Cervical cancer is a dreadful disease.
The HPV (said to be carried by one in ten girls under 16) is sexually transmitted and once it enters the cervix causes cell mutation which, if undetected, will lead to cancer.
Once the cells are past the pre-cancerous stage, treatment is notoriously drastic. ‘Women who are caught early and end up having just a hysterectomy are the lucky ones,’ says consultant gynaecologist Thomas Ind from the Royal Marsden Hospital and St Thomas’.
‘It is not uncommon to see a woman in her early 30s who has lost her bowel, vagina, bladder and colon to the disease.’
Quickly introduced
In that context, perhaps it is laudable that the vaccine programme has been introduced in the UK so quickly (the drug was approved by the European Union only in September 2007 and has yet to receive full approval by the American FDA).
Indeed, there has been some criticism that the Government had not acted as quickly as European countries such as France, Italy and Germany who began their programmes a year earlier.
But look more closely and it is not hard to see why many British experts are uneasy about the rush to vaccinate all our young girls.
Cervical cancer may be a nasty disease, but it is also, thanks to our world-class screening programme – where all women from 25 to 64 are eligible for a free cervical screening test every three to five years – very rare in the UK.
Around 3,000 cases are diagnosed each year and about 940 women die. While this is 940 too many, it equates to less than three deaths per 100,000 of population and does not even begin to compare with the carnage caused by breast or lung cancer.
We have one of the highest rates of teenage sexual activity in the developed world. We should be experiencing an epidemic of cervical cancer,’ says Thomas Ind.
‘The fact that we are not is down to our screening programme. I fear that introducing another preventative method will dilute both money and attention away from this.’
Indeed, one of the main worries about the mass vaccination is that girls will then feel ’safe’ against cervical cancer and ignore the screening programme.
That would be nothing short of disastrous, because the jab gives protection only against HPV 16 and 18 which are implicated in around 70 per cent of cervical cancers.
Smear tests still needed
There is still a 30 per cent chance that another strain could cause cancer, making it vital that women go for regular smears.
Cervarix is also very new – large-scale trials go back only six years – and there is no way of knowing just how long protection will last.
The worst case scenario is that the Government could be paying a fortune for a vaccination that may protect young girls for only the next six or so years. So just as they hit the peak years for sexual activity they are totally unprotected.
Furthermore, with the possibility that women will stop going for smears because they think they’re protected, the vaccination programme could end up being counter-productive and costing more lives than it saves.
But according to Dr David Elliman, a consultant community paediatrician who works for Haringey NHS Trust and Great Ormond Street Hospital and sits on the cervical cancer screening board, this is an unlikely scenario.
‘The girls receiving the jab are many years away from the age of screening,’ he explains. ‘In addition, in all the literature it is made extremely clear that the vaccination is not a substitute.
‘For all its merits, our screening process doesn’t prevent cancer, it simply picks it up at an early stage. The vaccination is the only thing that actually prevents HPV 16 and 18 from causing cancer.’
However, some people feel the programme is a case of taking a sledgehammer to crack a nut. ‘Six million women carry the HPV virus at any one time,’ says Chris Woollams, founder of the charity CancerActive and a former biochemist.
Protection
‘In the majority of cases the immune system renders it harmless. Only 3,000 women get cervical cancer each year and less than 1,000 actually die.
‘Looking at those figures, you have to ask whether the most sensible response is to put a drug that has little long-term safety and efficacy data behind it into the immune system of all our young girls and women?
‘The best protection against contracting HPV and therefore cervical cancer is to use a condom. It gives you 100 per cent protection. For a fraction of the money you could run a very effective sex education campaign.’
The Government refuses to release the cost of the vaccination programme, claiming commercial confidentiality. But given that, privately, Gardasil costs around £160 per injection, it will not be cheap.
In July, the British Medical Journal calculated that by using Cervarix – cheaper than Gardasil because it protects only against strains 16 and 18 and not 6 and 11, the strains responsible for genital warts – the Government will save up to £18million in the first year alone.
Either way, huge sums are involved and there has been criticism that drug companies funded charities and doctors to lobby the Government in the battle to ensure the programme went ahead.
In America, where the vaccination programme using Gardasil has been in place since June 2006, some experts are now expressing unease about the scheme.
Twenty seemingly healthy girls died within a few days of being injected with the vaccine which has a similar generic make-up to Cervarix.
These deaths have been dismissed as coincidence by Merck who make the American jab, although both Cervarix and Gardasil list fainting, dizzying and sore arms as side-effects.
Here in the UK, the awareness group JABS is reporting an upsurge in calls from parents who are worried about possible side-effects.
Last month, an article in the New England Journal Of Medicine claimed that serious questions regarding the overall effectiveness of the vaccine remained unanswered.
It pointed out that studies into the vaccine were carried out on girls aged 15 to 24 so there is no way of knowing how the drug will affect pre-pubescent girls, how long it will last and whether there was the potential for interference with the body’s natural defence against other HPV strains.
So parents are being faced with an agonising decision. Do they say no to the vaccine and risk their child contracting a dreadful disease.
Or do they put their trust in a drug for which evidence of safety and efficacy is probably insufficient and at worst may do harm?
Source | See Also: Study finds higher rate of reactions to HPV shot | Researchers Question Wide Use of HPV Vaccines | CDC reports almost 8,000 adverse reactions to “Gardasil” HPV vaccine in U.S. | Is HPV Vaccine to Blame for a Teen’s Paralysis? | Alberta to offer HPV vaccine this fall | Discovery of HPV in male oral cancers leads to vaccination call | HPV vaccination program raises concerns in B.C. | Gardasil shots have earned a painful reputation | Perspective on the HPV vaccine | Deaths associated with Merck’s HPV vaccine (Gardasil), over 3500 adverse affects reported | Political Intrigue in Merck’s Push for Mandatory HPV Vaccinations
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