Cervarix: the simple injection causing so much controversy

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Cervarix: the simple injection causing so much controversy
http://www.telegraph.co.uk/health/women_shealth/4986930/Cervarix-the-simple-injection-causing-so-much-controversy.html

Telegraph

16 March 2009

The cervical cancer jab Cervarix is currently under scrutiny after nearly 1,500 Britons have experienced adverse reactions to it.

By Bryony Gordon
Last Updated: 6:57PM GMT 13 Mar 2009

Carly Steele has not felt right since receiving the cervical cancer vaccine, Cervarix

Amanda Steele first noticed a change in her daughter Carly last summer. The normally exuberant 13-year-old had lost all of her energy. Whereas normally she would have spent her days outside on the trampoline, she now found it difficult to leave the sofa. It was even a struggle to walk unaided to the bathroom.

The blackouts, when they came, were more worrying. Mother would find daughter out cold on the floor of their Stockport home. Every joint in Carly's body ached, and simple tasks such as washing her hair became impossible. Carly, on the brink of womanhood, suddenly seemed more like a toddler. It is six months now since she last attended school.

It is like the light has gone out in her eyes," says her mother. "It is absolutely heartbreaking to watch."

At first, the doctors blamed vertigo. Then came a diagnosis of the balance disorder Labyrinthitis. Next, ME was suggested. Amanda is not convinced any of these conditions are implicated. What she believes is that Carly's condition is related to the cervical cancer vaccine she received last year.

"The doctors all look at me like I am an idiot when I bring up the possibility of the jab having this effect on her, but she was a healthy, happy girl before she had it and now she isn't, and I simply can't believe that it has nothing to do with it."

This week, relief of sorts arrived for the Steele family in the shape of a government report detailing the 1,340 instances of adverse reactions to the vaccine, Cervarix. Some girls have suffered paralysis, others convulsions; and some, like Carly, have experienced sight problems (in addition, Carly has now developed severe heat intolerance). Nausea, muscle weakness, fever, dizziness and numbness have also been reported.

This news has further pushed the subject of cervical cancer into the public consciousnesss. The tragic case of Jade Goody who is dying of advanced cervical cancer has, in some areas of the UK, led to a 30-fold increase in the number of women attending screening programmes. And last Friday, Health Minister Ann Keen announced that a panel of experts would now review the age at which young women are sent for cervical cancer screening. This follows criticism of the decision to raise the age from 20 to 25 four years ago.

Professor Mike Richards, National Cancer Director at the Deparment of Health, who will oversee the review, says that it was "important that we look at any emerging evidence so that we can be sure, and can assure young women, that this [the current screening age] is still what is best for their health".

Since the Department of Health announced a national vaccination programme against cervical cancer last June, the scheme has rarely been out of the headlines. The first 700,000 12- to 13-year-olds were vaccinated with Cervarix vaccine last September, and this autumn it will be made available to all girls under the age of 18.

Scientists who thought that the public would embrace the chance to immunise against the virus that causes cervical cancer, human papillomavirus (HPV), were wrong. Not since MMR – and perhaps because of that – has a simple injection caused so much controversy.

First, some parents became uneasy that girls as young as 12 were to be immunised against a virus that is transmitted only through sex. It was dubbed the "promiscuity jab". When it was pointed out that the vaccination is most effective before a person becomes sexually active, those fears were replaced with another: that, in other countries, there had been serious reactions to the vaccine.

In America, there were 7,802 reports of "adverse events" linked to Gardasil, the vaccination of choice there. The Spanish government briefly halted the vaccination programme in Valencia after two girls suffered serious side-effects that required hospitalisation.

All of these problems occurred in girls who had been vaccinated with Gardasil. But Dr Latha Parvataneni, head of medical affairs for the UK suppliers of the vaccine says that "the majority of reactions have been proven to be because of the process
of the vaccination rather than the vaccine itself".

In the UK, secondary school girls have received Cervarix, not Gardasil. Manufactured by GlaxoSmithKline, Cervarix is cheaper and does not offer the additional protection against genital warts that its US equivalent provides. Helena Bates, of GlaxoSmithKline, said that the company and the Government were confident in the safety of the vaccination. "The number of cases are to be expected within the population, and are in keeping with other vaccine programmes."

The NHS has not changed its advice in the light of these adverse reactions. A Department of Health spokesperson said: "The HPV vaccination programme prevents cervical cancer and will save the lives of up to an estimated 400 women each year. Both HPV vaccines have met the rigorous safety and efficacy standards required for licensing in Europe and elsewhere. It is irresponsible to raise fears over vaccine safety in the absence of scientific evidence that points to safety concerns."

Jackie Fletcher who runs Jabs, a support group for people who believe that they have been damaged by vaccines, believes differently. She says there is anecdotal evidence that stretches back to the beginning of the programme in September. "There is a girl who has been in Liverpool's Alder Hey Hospital ever since she had her first vaccination [girls have a course of three jabs]. At one point, she was paralysed from the waist down."

Doctors have discounted any link to the vaccination, but Fletcher feels strongly that the Government needs to take a closer look at Cervarix. "It has been rushed through. Our daughters are being made to be guinea pigs."

At Cancer Research UK, Dr Anne Szarewski offers a different, more positive view of the vaccine. "There has been a lot of speculation about why it was chosen, and cost may have come into it, but it is emerging that Cervarix might offer longer-lasting protection than Gardasil, and better protection regarding the types of HPV it defends against, which are the ones that cause the majority of cervical cancers."

Unike many cancers, this one strikes the young. "It leaves a lot of children without mothers," says Dr Szarewski. The disease kills 700 women in the UK a year; thanks to the introduction of a screening programme involving smear tests, cases have halved in the past 20 years (symptoms, such as bleeding, often do not appear until the disease is in its final stages, and so screening is essential).

Do we really need to vaccinate so many girls against a disease that kills so few? In blunt terms, is this cost-effective, especially when smear tests are so good at catching abnormal cells before they become cancerous? "I think that actually the screening programme is as effective as a vaccination programme," says Dr Szarewski, "but then I think about all the women who don't get cancer but do have to go through pretty traumatic procedures to ensure that is the case – 300,000 women a year have to have very invasive treatment. If those figures go down because of the vaccination programme, that is a good thing."

When the age at which women are called for screening was raised from 20 to 25, Katie Brickell fell foul of the change, and was refused a smear test each of the three times she asked because she was too young. On her 25th birthday last year, she finally received a letter inviting her for a smear, but it came too late – a year earlier she had been diagnosed with cervical cancer.

She has had several sessions of chemotherapy and, for now, there is no trace of the tumours that were in her groin and lungs. But she is angry that her ordeal could have been prevented had she been allowed to have the smear earlier. On Wednesday, she will attend a rally in Parliament Square, where a petition of 10,000 signatures calling for the screening age to be lowered will be handed to Downing Street.

With the announcement of the screening programme review, it would seem that those signatures are already making a difference. "I worry slightly that one effect of the jab might be that in 10 years' time, women won't bother to go for their smear," says Katie. "And it is vital that they continue, firstly so the effectiveness of the vaccine can be measured and secondly because the vaccine doesn't protect against all types of HPV. The vaccine would not have saved me from this experience. That is something to think about.

"Anybody who is worried about the safety of any vaccine should speak to their GP, who is medically qualified to discuss their concerns, or visit www.immunisation.nhs.uk where they can find more information about all vaccinations routinely given to children and young people."