It has been hailed as the wonder jab that will prevent thousands of young women suffering the same terrible fate as Jade Goody. But as parents across Britain rush to have their daughters vaccinated, others are adamant that it has triggered alarming side-effects…
Amanda Steel is flicking through last year’s diary, trying to pinpoint when this nightmare began. It was the summer holidays when she first noticed that Carly, her eldest daughter, was seriously out of sorts.
‘Anyone who knew Carly before will tell you what a chatterbox she was. She had so much energy she drove us mad. But suddenly, she was a different girl. It was heartbreaking to watch,’ says Amanda.
‘I struggled to wake her in the mornings and she barely spoke all day.’
By August, 13-year-old Carly, was barely ever awake. Consumed with exhaustion and complaining of dizziness, she was confined to the bed or the sofa, and had to grip the furniture to steady herself whenever she took a few steps.
‘And that’s when the blackouts started,’ says Amanda. Several times she found Carly collapsed after what she described as a ‘split-second blackout’.
Her joints ached so much that washing her own hair was unmanageable. She has not attended school since September, and considers it ‘a good day’ if she manages to walk to her grandmother’s house at the end of the street.
Her mother says that within weeks she was transformed from a vivacious, sociable girl into ‘an old lady’. Baffled doctors have diagnosed her with vertigo, labyrinthitis (a balance disorder), and even chronic fatigue syndrome.
Then she was diagnosed with depression and sent for counselling when one doctor thought her illness might be psychosomatic.
That’s when Carly, who describes her daily existence as ‘miserable’, and her parents, Amanda, 35, and Stuart, 50, lost patience.
‘Carly was getting worse and I felt powerless, so I did some research and couldn’t believe what I found,’ says Amanda.
She discovered, on the internet, that Carly’s symptoms tallied almost exactly with a list of adverse reactions to Gardasil, the American version of the cervical cancer vaccine.
Could it have been coincidence that just weeks before Carly first showed signs of illness, she had been injected Cervarix – a similar vaccine made by GlaxoSmithKline. Her school had taken part in the trial that preceded the national roll-out of the Government’s vaccination programme, targeting 12- to 18-year-old girls.
A report released by the drug safety watchdog, the Medicines and Healthcare products Regulatory Authority (MHRA) last month showed that, of the 700,000 schoolgirls vaccinated last year, more than 1,300 of them had officially reported an adverse reaction.
They ranged from minor complaints, such as sore arms and faintness, to the more worrying – convulsions, sight problems, nausea, muscle weakness, dizziness, numbness in the limbs and pain in the joints.
Admittedly, that is a tiny proportion of the girls who have upped their protection against a dreadful disease. But Amanda is by no means the only parent in the country to believe that Cervarix is not safe.
Many other parents have seen their daughters fall ill within days of receiving the jab. And, like Amanda, they know how difficult it is to report a suspected adverse reaction to this vaccination. Their stories beg the question of how many girls may have been ill as a result.
Last week came the news of a move to vaccinate boys too. Although they can’t contract cervical cancer, they can contract the human papillomavirus (HPV) and pass it on.
Dr Anne Szarewski from Cancer Research UK says it was likely that boys would be vaccinated to ensure widespread immunity, and remove the stigma associated with the injection, dubbed by some as ‘the promiscuity jab’ because it vaccinates against a sexually transmitted infection.
In some parts of the UK the uptake rate is almost at 90 per cent – but vaccinating boys too, would make up the shortfall.
Amanda says it took endless phone calls and visits to the doctor before she heard any mention of the MHRA’s ‘yellow card’ scheme. The scheme monitors adverse drug reactions and receives reports from healthcare professionals and now allows reporting by patients too.
Every time I mention HPV, the shutters come down. I’ve been treated like an idiot. That’s why we didn’t have a yellow card submitted until February,’ she says.
By then, the nationwide vaccination programme was well underway. It came in last September, promising 70 per cent protection against cervical cancer to every girl under 18 by 2011.
It works by creating an immunity against the two strains of the HPV virus which are responsible for 70 per cent of cervical tumours.
‘It made cervical cancer ‘one less thing to worry about,’ says Amanda.
But amid the enthusiasm for Cervarix, it was hard to hear the dissenters – those who questioned injecting every prepubescent girl with a drug that had been tested primarily on girls aged 15 to 24.
Little was known about how long the vaccine’s protection would last and whether booster shots were necessary. Would a girl injected at 13 still be protected at 18 when she was more likely to be sexually active?
Others wondered whether the Cervarix programme was worth doing at all. Millions of women all over the world carry the HPV virus, and in the majority of cases the immune system renders it harmless.
While manufacturer and ministers alike claim the vaccine could save 700 lives a year, in real terms that accounts for just 0.1 per cent of the girls vaccinated in 2008.
Campaigners say the money would be better spent lowering the age at which women are eligible for free cervical smears, from 25 to 20. Cervarix does not reduce the need for regular check-ups and there are 30 per cent of cervical cancers that it offers no protection against.
Now mothers such as Amanda are left wondering if the risks outweigh the benefits.
So convinced is she that the vaccine is to blame for Carly’s illness that she won’t allow her younger daughter Katy, 11, to have it. When she contacted JABS, the vaccine support group, she found she was not the only mother in this position.
Cheryl Cave’s 12-year-old daughter Ashleigh was struck down by a mystery illness within minutes of having the HPV vaccine, and developed partial paralysis. She has been in Alder Hey Children’s Hospital, Liverpool, since last October.
Immediately after the injection, she suffered dizziness and headaches, then blackouts. She was briefly admitted to hospital, where doctors gave the initial diagnosis of ‘vertigo and generalised myalgia. Probably due to recent vaccinations’.
But when her condition worsened and she lost the feeling in her legs, doctors refused to link the vaccine to her illness. They maintain that she has demonstrated ‘no pathological reaction’ to the jab.
But, despite CT and MRI scans, and physiotherapy, they are no closer to finding a medical explanation.
‘The doctors say it’s all in her mind,’ says Cheryl.
Meanwhile, Ashleigh complains of pain in her spine whenever she moves, confining her to hospital for months.
‘I’m practically living in the hospital. It’s so stressful seeing her like that,’ says Cheryl.
Cheryl adds: ‘I told them it started with the HPV, but they will not mention her illness and the vaccine in the same sentence. They say it’s nothing to do with HPV. If it’s not, then it’s one hell of a coincidence.’
But coincidence is exactly what the experts say it is.
Dr Loretta Brabin, reader in women’s health at St Mary’s Hospital, Manchester, was the principal investigator in the trial of Cervarix, of which Carly Steel was a part.
She insists that as the vaccine contains no live HPV virus, it is safe.
‘It artificially mimics the HPV virus well enough to make the body produce the antibodies that guard against it.
‘Vaccines generally contain adjuvants which enhance the effect of the vaccine, but these are well tested, so the risk of a serious reaction is low,’ she says.
‘That’s not to say that reactions never occur. If you give injection doses to a large enough population, there will always be reports of adverse reactions. Most are not serious and can be explained by an underlying condition, or the fact that the person happened to get ill at the time of the injection.
‘When a reported reaction is worse than would be considered normal, it is most likely to be a coincidence. And if the agency that monitors these reactions considered problems were occurring more often than normal, it would consider stopping the vaccine programme.’
And a spokesman for GlaxoSmith-Kline says: ‘We understand that every adverse reaction related to vaccination is distressing for the girl and family involved and we take these reports seriously. We work closely with the MHRA to monitor any reactions to the vaccination.
‘The majority of adverse reactions reported have been related to the process of injection, rather than to the type of vaccine, i.e. the most common side effect is soreness at the site of injection, which you would expect to see in any vaccination programme.
‘We remain confident in the safety profile of Cervarix which was extensively tested through clinical trials and has been licensed for use in girls and women in the UK.’
But that is of little comfort to Cathy Chandler from Surrey, whose 12-year-old daughter Sarah has just been diagnosed with chronic fatigue syndrome. Her illness began a week after her first injection in September, and she has barely attended school since November.
‘I know I can’t prove the connection, but I’m as certain as I can be,’ says Cathy.
Sarah had the second in a course of three Cervarix jabs in October. She felt ill and lethargic following the first dose. But after the second, her condition deteriorated. She was listless and her throat felt, and still feels, as if something was stuck in it. Antibiotics did nothing to ease it.
‘It took me a while to make the connection to Cervarix, but once I had it all made sense,’ says Cathy, 53, a part-time administrator.
‘I panicked and thought, “What’s happened to her? What have they done?”‘
In recent weeks, her health has improved enough for her to attend school for nine hours a week, but it looks unlikely that she will be back full-time for many months.
While Sarah’s doctors have never said they believe the vaccination is the cause, they have not ruled it out.
Sarah’s doctor advised against her having the last injection of the course.
‘Sarah was worried about missing it,’ says Cathy, ‘The doctor explained that as HPV is sexually transmitted, you can reduce your risk of contracting it by avoiding unprotected sex, when the time comes.’
But Cathy adds: ‘She didn’t say Sarah’s illness was linked to the HPV vaccine in particular – any vaccine could potentially have had the same effect.’
Cathy is now in contact with Julie Smith, whose daughter Lauren, 13, attends the same school as Sarah and has also missed weeks of school through illness.
After her second jab in November, she developed a painful sore throat.
‘She said she had numbness in her arms,’ says Julie. ‘She was very pale and was so tired she could barely get out of bed.
‘I made her go to school, but she was always in the sick bay.
‘I have asked her GP repeatedly to note my concern over the vaccine, but they say her illness could be caused by anything. She’s through the worst of it now, but to hear that her friend Sarah has been diagnosed with chronic fatigue syndrome is obviously worrying.’
And it’s not just 12- and 13-year-old girls that may have been affected. Eighteen-year-old Leah Mann, from Nottinghamshire had her first injection in January.
Ten days later, when she was at work in a fish and chip shop, she felt unwell and collapsed. When she came to, she had no feeling from the waist down.
‘It was terrifying,’ she says. ‘I went to hospital and while I was waiting to see a doctor the feeling in my right leg came back. But it took two weeks for it to return to my left leg.’
More worryingly she now suffers full-blown seizures. Although doctors are at a loss to explain why she has developed what appears to be epilepsy, they are more inclined to believe it is associated with the antidepressant medication she had been taking (with no adverse sideeffects for more than a year) than with the vaccine.
‘I’ve had my driving licence taken away and I’ve had to give up my college course,’ she explains.
Leah had been studying equine management, but, because of her seizures, the college’s insurance can’t cover her horseriding. She will remain housebound until her specialists find the right medication to control her condition.
‘It’s five weeks since we last saw her neurologist, and she has had 30 seizures in that time,’ says her mother, Tracey, 42.
Leah adds: ‘Looking back, I felt lucky to have had the injection. But why has my doctor not allowed me to have the second and third doses?’
While GlaxoSmithKline says that ‘Cervarix had to undergo rigorous testing with large numbers of people in numerous studies’ and was ‘found to be generally well tolerated’, questions over the safety and efficacy of Cervarix remain.
Dr Richard Halvorsen, author of The Truth about Vaccines, says: ‘The HPV vaccines have been introduced at breakneck speed and, in my view, without adequate testing.
It is already the most profitable vaccine ever made and the worry is that it is being introduced too rapidly, for the financial gain of its manufacturers and with too little regard for the health of our young women.
‘These parents may never know for certain whether the vaccine caused their daughters’ disabilities.
‘I would not encourage my own daughter to have it. At the moment we know far too little to be sure – and we know far too little to roll it out on a national scale.’
However, those who know the devastation that cervical cancer can cause are in no doubt that the benefits outweigh the possible risks.
Meanwhile, Robert Music, director of the cervical cancer charity, Jo’s Trust says: ‘Quite simply, the jab could save your daughters’ lives,’
Even among Cervarix’s critics, you will not find anyone who disagrees with this sentiment. But those whose health has deteriorated since they armed themselves against the disease would warn against the blind acceptance of a wonder-jab.
Blast from the Past: http://www.medscape.com/viewarticle/711461
October 28, 2009 (Baltimore, Maryland) — Investigators are reporting a case of motor neuron disease after immunization with the quadrivalent vaccine Gardasil. The Merck product is designed to prevent infection with several types of human papillomavirus.
Presenting here at the 134th annual meeting of the American Neurological Association, researchers describe a case of rapidly progressive disease leading to the death of a 14-year-old girl.
Symptoms began 2 months after the last dose of Gardasil.
“Pathological features support the temporal association of the clinical presentation and vaccination and provides supporting evidence that immune-mediated reactions to the nervous system are potential risks after Gardasil vaccination,” Catherine Lomen-Hoerth, MD, director of the Amyotrophic Lateral Sclerosis Center at the University of California–San Francisco, told the meeting.
“Our patient received 3 doses of Gardasil with symptom onset 2 months after her last dose,” the poster presenters wrote. “Despite treatment with aggressive immunosuppression, her weakness relentlessly progressed and she died of respiratory failure 21 months after the onset of her weakness.”
Postmortem evaluations revealed widespread infiltrates of T lymphocytes and macrophages in the grey and white matter at all levels of the spinal cord. Researchers also report extensive demyelination and severe loss of motor neurons.
In September, investigators presenting at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting reported cases of autoimmune disorders after immunization with Gardasil.
Two groups presented at the meeting — one identified a case of multiple sclerosis after vaccination and the second a case of neuromyelitis optica.
Other Reports of Autoimmune Disorders
Presenter Maria Bouktsi from the Interbalkan European Medical Center in Thessaloniki, Greece, told Medscape Neurology that her team is questioning whether the immuno-stimulatory properties of the human papillomavirus–like particles of the vaccine are triggering adverse effects in vulnerable patients.
It is the same question that researchers asked in a recent issue of Multiple Sclerosis (2009;15:116–119). Ian Sutton, MD, from St. Vincent’s Hospital in New South Wales, Australia, and his team reported 5 cases of multiple sclerosis after vaccination with the drug. The group reported in January that patients presented with multifocal or atypical demyelinating syndromes within 21 days of immunization.
No definitive conclusions can be made based on this report, Dr. Sutton and his team noted. “It should not be overlooked that several epidemiological studies indicate that viral infection is associated with a threefold increase in the risk of a multiple sclerosis relapse,” write the researchers.
7 More Cases
Lead investigator of the second group presenting on this topic said that he agrees that postmarketing pharmacosurveillance is necessary to improve safety. “[Human papillomavirus] vaccines elicit a strong inflammatory systemic immune response,” said Til Menge, MD, from Heinrich-Heine University in Düsseldorf, Germany.
His group suggests that it was this inflammatory response that may have triggered a case of fulminant neuromyelitis optica in a previously healthy 17-year-old girl.
Investigators have not established a causal relationship, but they are asking clinicians to closely monitor patients for any emerging side effects.
The researchers have disclosed no relevant financial relationships.
American Neurological Association 134th Annual Meeting: Poster WIP-19. Presented October 13, 2009.