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Making Trouble

MagazineJuly 2015 (Vol. 26 Issue 4)Making Trouble

The HPV vaccines that protect against cervical cancer have twice the number of adverse event reports as any other vaccine

The HPV vaccines that protect against cervical cancer have twice the number of adverse event reports as any other vaccine. And it could be down to the unique way these vaccines are made.

There's something very wrong with the HPV vaccines. Given to young teenage girls to prevent cervical cancer (and officially recommended for boys, too, to prevent other cancers), the jabs have a track record of serious adverse events-usually life-threatening reactions-that are double the number seen with any other vaccine. So far, they have generated 20,000 recorded events in the UK and 39,000-including 227 deaths-in the US.

Critics fear it's to do with the way the two HPV (human papillomavirus) vaccines-Gardasil and Cervarix-have been manufactured. Both have used a new method of processing that involves a genetically modified virus. Vaccines traditionally use an attenuated (weakened) form of virus, but the two HPV vaccines instead employ virus-like particles (VLPs), known as L1 proteins, to trigger immune responses.

The vaccines could also include insect DNA, as Dr Sin Hang Lee at the Milford Hospital in the US discovered when he carried out an analysis. Cervarix, which the UK used until 2012, when it was replaced by Gardasil, includes aluminium salts, and doses can also include residual amounts of insect and bacterial cell proteins. In fact, if there's insect protein in the vaccine, then insect DNA is also present. GlaxoSmithKline, Cervarix's manufacturer, never revealed the potential insect contamination until it was discovered in Merck's Gardasil.

But Dr Lee discovered more than just insect contamination in Gardasil. During the manufacture of the vaccine, Merck "may have inadvertently created a new chemical compound composed of HPV L1 fragments chemically bound to aluminium nanoparticles", he said.1 Dr Lee's findings were also independently replicated and confirmed by Laurent B'elec at the Sorbonne in Paris.

In response, America's drugs regulator, the Food and Drug Administration (FDA), said that DNA fragments are to be expected, as the HPV L1 gene is used in the vaccine's manufacturing process. It's inevitable, but the fragments aren't harmful, it said.

SaneVax, a lobby group formed by the parents of girls harmed by the vaccines, which helped fund Dr Lee's research, is concerned that the FDA statement makes no mention of the possibility of DNA fragments attaching themselves to the aluminium in the vaccines. It's also not been scientifically confirmed that gene fragments, if bound to aluminium, are harmless. "Our request for scientific evidence has been totally ignored," a SaneVax spokesman said.

Dr Lee also noted that the HPV DNA fragments were forming specific configurations-known in chemistry as 'non-B DNA conformations'-which can cause mutations, and multiple neurological and psychiatric disorders. And it's the autoimmune reactions to both HPV vaccines that are off the chart.

Even doctors are becoming worried about the huge number of reactions. More than 200 French physicians have signed a letter to the European Parliament, asking for a moratorium on the use of the vaccine until its safety and benefits are clearly delineated. The lead signatory is Dr Philippe de Chazournes who, in the letter to Marisol Touraine, Europe's Minister of Social Affairs, is calling for a committee to investigate the true risks and benefits of the vaccine, and especially Gardasil, the leading HPV vaccine used around the world.

Presenting the letter to the European Parliament last April, Euro MP Mich`ele Rivasi declared it was time the voices of the vaccine's victims were heard, and that funding should now be set aside for the research and development of a new, safer HPV vaccine.

It's also becoming an issue in the law courts. Victims in the US and UK cannot sue the vaccines' makers, as they have been indemnified by their respective governments, but similar protection isn't offered in other countries. Cases are currently going through the courts in India and France, and the latest is in Spain, where proceedings are soon to begin in the case of Zuri~ne Jim'enez Guere~no, a teenage girl who has become physically disabled after being given the Gardasil vaccine.

In Japan, the health ministry stopped recommending the HPV vaccine after receiving hundreds of reports of numbness and pain. The decision was made in 2013, four years after the vaccine was introduced. Although the vaccine remains available to local health officials, they have been told not to promote it.

In Denmark, a television production company has produced a major new documentary, The Vaccinated Girls: Sick and Betrayed, which aired on TV2, one of Denmark's national TV channels, last March. In the programme, Dr Louise Brinth of Frederiksberg Hospital in Copenhagen, who examined 80 girls who had suffered severe reactions after having the HPV jab, said: "We see a pattern that screams to heaven, and that should be examined by some solid research."

A sporting chance

Are some girls more at risk than others? No one can be sure, but Jesper Mehlsen, who is also from Frederiksberg Hospital, researched Gardasil on behalf of the manufacturer, and found a strong association with girls who are athletic and who participate in sports at a very high level. His observation is supported by the many stories of high-achieving athletic girls who are now unable to even get out of bed after being vaccinated.

Mehlsen, who also appears in the Danish TV2 documentary film, always advises girls not to participate in any sports or strenuous exercise for several weeks before having the vaccination.

Sporty or not, vaccine proponents argue that the HPV vaccine is safe and effective, and that only a tiny minority of girls suffers an adverse reaction. This positive stance is supported by a recent study of more than 260,000 Canadian schoolgirls (aged 14 to 17), which found that Gardasil reduced the rate of dysplasia, or abnormal cell growth, by 5.7 per 1,000 girls (0.006 per cent), and can also help prevent anogenital warts. 2

There are around 100 different strains of HPV, although only four-types 6, 11, 16 and 18-are targeted by the Gardasil vaccine. HPV is a highly contagious sexually transmitted disease (STD) spread by bodily contact. Other strains can also cause cervical cancer or genital warts, as well as cancers of the penis, anus, head, neck and throat (not targeted by the vaccines), although the body's immune system can clear the vast majority of HPV infections.

And the vaccine advocates are right: the rate of 'serious' reactions is low, seen in around 0.3 per cent of cases, or one in 300 girls vaccinated. But a 'serious reaction', as defined by the FDA, is death, a life-threatening reaction, hospital care, disability or permanent damage.

Yet there's another reaction to the vaccine that is far more common: the jab seems to trigger one of 80 different autoimmune reactions-where the body starts attacking itself-in around 3.3 per cent of people, or one in 30 girls vaccinated. Even then, it may be argued that the reactions are coincidental and don't prove that the vaccine was the cause.

More than just coincidence?

But if so, that's an awful lot of coincidences going on. Figures released to the UK's House of Commons last December revealed 7,948 reports of adverse reactions-including 2,529 'serious' reactions-associated with seven million doses of Gardasil or its predecessor, Cervarix, in the UK. Assuming that the recommended three-dose course was followed, around 2.3 million girls in the UK have had the HPV vaccine. This suggests there were 341 adverse reactions per 100,000 girls vaccinated (0.34 per cent), and 108/100,000 (0.11 per cent) were 'serious'.

But the number of autoimmune reactions after vaccination leaps 10-fold. And according to one clinical trial, around 240 of the 7,378 girls given Gardasil suffered an autoimmune disorder as a result-a 3.3 per cent reaction rate. Reactions have included sudden collapses, seizures, muscle pain, disabling fatigue, paralysis, brain inflammation, arthritis, lupus and multiple sclerosis. The rate is slightly lower with the new version of the vaccine, Gardasil 9, at 2.4 per cent.

A similar picture has emerged in the US. According to the Vaccine Adverse Events Reporting System (VAERS), there was a total of 39,038 adverse reactions to an HPV vaccine up to last April, including 1,317 disabilities, 227 deaths, 686 life-threatening events, 12,470 requiring emergency-room care and a further 4,017 needing an overnight stay in hospital.

Of nuts and hammers?

Compare these rates with the number of new cases of cervical cancer each year. UK figures show 8.8 new cases and three deaths per 100,000 people each year. That translates to an annual rate of 0.008 per cent of new cases of cervical cancer and 0.003 per cent of deaths, making it the fourteenth most common cancer. And it's a cancer that's on the wane, with just 3,000 new cases reported in the UK and 12,000 in the US every year (see box: The decline and fall of cervical cancer, page 28).

But something odd has been happening with cervical cancer cases since the vaccines were introduced. The VAERS figures reveal that, after being vaccinated, 102 girls developed cervical cancer, 597 had an abnormal Pap smear and 265 had cervical dysplasia (abnormal cell growth)-the very things the HPV vaccine is meant to prevent.

This phenomenon has also been observed by researchers at the University of Texas. After tracking the health of 592 women aged 20 to 26-512 of whom had received an HPV vaccine-the researchers discovered that those who had been vaccinated were almost twice as likely to have 'high-risk' types of HPV, and not from the four viruses covered by the vaccine.

Also, according to the Danish documentary, the youngest woman in Denmark to die from cervical cancer in 2008-the year before Gardasil was introduced in that country-was aged 30 whereas, in 2012, the youngest to die was just 20.

There has also been a steep increase in death rates from cervical cancer in Denmark. The rate had been falling steadily from 140 deaths in 2005 until 2011, when the cancer claimed 80 lives, but then began to rise in 2012 to 100 deaths and rose again in 2013 to 119 deaths.

Studies presented to the FDA by Merck before Gardasil was approved in the US in 2006 also show that women exposed to cancer-causing HPV strains before vaccination were 44 per cent more likely to develop precancerous lesions afterwards.

And critics point out that the vaccine offers protection against cervical cancer for only four years. As 11- to 13-year-olds are targeted, any protective effects will have worn off by the time that most of them are sexually active.

I told you so

Several employees and associates of Merck, Gardasil's manufacturer, have broken ranks over the years. The first to do so was Dr Diane Harper, a leading researcher, who described both HPV vaccines as "useless and dangerous". Around 90 per cent of HPV infections clear themselves within two years, she said.

In an interview quoted by CBS News, Dr Harper said: "The rate of serious adverse events [from Gardasil] is on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year." But Dr Harper later said she had been misquoted and has distanced herself from the reported comments.

Not so, or not yet, for Dr Bernard Dalbergue, a former Merck employee, who has said: "Gardasil will be the biggest scandal in medical history. The full extent of the Gardasil scandal needs to be assessed. Everyone knew when this vaccine was released on the American market that it would prove to be worthless."4

Vaccine proponents claim this is all so much sour grapes from a former employee, and maintain that the HPV vaccines are saving lives and don't cause neurological problems-or any other problems, for that matter.

They point to several studies that have never found any long-term reactions to either HPV vaccine, including one-involving nearly a million young girls in Denmark and Sweden-where even neurological problems weren't noted afterwards.5
It's hard to square that circle with the thousands of young girls whose lives have been ruined by debilitating symptoms that came on almost immediately after vaccination. From being active, even sporty, teenage girls, they are now living twilight existences.

Freda Birrell of SaneVax is putting together a dossier to present to the UK's Department of Health. She wants to hear from parents whose daughters' health has declined dramatically since having had an HPV vaccine. If you have a case for Freda, contact her via email at jeanfreda8@btinternet.com. She isn't anti-vaccine-but she's sure there's something very wrong with the HPV vaccine.

The decline and fall of cervical cancer

Cervical cancer has been in decline since the 1950s. Although the Pap (Papanicolaou) cervical smear test took the credit, the decline occurred before the test was introduced. By 1992, cancer and death rates had fallen by 60 per cent.

Today, cervical cancer is only the fourteenth most common cancer, and just 12,000 new cases in the US and 3,000 in the UK are diagnosed each year. Treatment-usually radiation with chemotherapy-is effective, and 75 per cent of patients achieve the five-year survival rate. As a result, there are 4,000 deaths in the US and only 900 in the UK every year.

It's still a major cause of death in the developing world, though, where more than 80 per cent of all cases worldwide occur.
Most cases of cervical cancer are caused by HPV strains, and two of these-HPV-16 and HPV-18-are responsible for 70 per cent of all HPV cases, and targeted by the Gardasil and Cervarix vaccines. However, other HPVs are responsible for the remaining 30 per cent of cervical cancer cases, and none of these is currently covered by vaccines.

In fact, there are more than a hundred HPV strains; 15 cause various cancers, and 40 of them can be sexually transmitted.

The day my life changed

Many thousands of girls have suffered long-term, debilitating health issues almost immediately after having an HPV jab. Some have died, but most have been ignored or ridiculed, and told they are attention-seeking or hysterical. Here are just a few of their stories. Judge for yourself.

Calli Kydd
had been diagnosed with attention-deficit/hyperactivity disorder (ADHD) when she was eight. At age 13, she was given the Gardasil vaccine. After the second dose, she awoke in the middle of the night, confused and unable to see. She was taken to hospital and, the following day, suffered a major seizure. She left a few days later, still suffering from dizziness, nausea, joint pain and itchy skin. She then suffered a major seizure, known as a 'tonic-clonic seizure', almost every month.

Calli was eventually diagnosed with epilepsy, and has not been able to go to school since 2014. She continues to have breathlessness, numbness, blurred vision, nausea and itchy skin. "When the school sent out the consent form and an information leaflet, no mention was made of any serious adverse reactions which can occur following HPV vaccination, although they're included on the patient information leaflet which is not seen by parents," said Calli's mother, Vivian.

Chelsea Townsend had missed just one day of school since starting nursery up to when she had the Cervarix vaccine at age 12. After having the jab in 2008, she started to suffer severe headaches and her doctors began to suspect epilepsy. After the third vaccine, she started to experience more headaches, tiredness, nausea and aching joints, and began to miss whole weeks of school. She became bedridden and slept 20 hours a day.

Chelsea was eventually diagnosed with chronic fatigue syndrome, and her doctors refused to even contemplate that the HPV vaccine may have been responsible. The local education authority put pressure on Chelsea to start attending school, and even threatened her mother with prison if she failed to comply.

Abbey Colohan was a healthy, happy 13-year-old when she had the Gardasil vaccine last September. She had a bad reaction straight away, and was left lying on a mat for an hour while the other girls were getting vaccinated. She suffered seizure-like jerking, rolling eyes, blurred vision, headache and nausea. After 80 minutes, her father, Martin, was called and he took her home.

He asked the school staff why an ambulance had not been called, and was told he was overreacting. Two days later and back at school, Abbey suffered another seizure and was taken to the local hospital in County Meath, Republic of Ireland. She spent six days in hospital, but various tests could not find a cause. Abbey is still unable to return to school. She continues to suffer vision problems, chest pains and stroke-like symptoms.

Amy Osborne has suffered severe fatigue and hair loss after completing her three courses of Cervarix in 2011. After several years of seeing consultants, she was given a diagnosis of chronic fatigue syndrome. She had been a happy, healthy young girl until having the HPV vaccine, says her mother, but since then, she has never been well.

She eventually decided to send Amy to a naturopath, who says her body is full of toxins, including aluminium, an ingredient used in both HPV vaccines.

Holly King was 13 when she was given her three Cervarix vaccinations over six months up to April 2012. She had 'flu-like' symptoms after the first two, but the family doctor said this was the result of winter viruses going the rounds.

After the third jab, her health deteriorated rapidly and a blood test revealed a very low white blood cell count. She was unable to go to school, and she spent most of her time sleeping.

She was diagnosed with autoimmune hypothyroidism, and a thyroxine drug was prescribed. Eventually, the diagnosis was changed to chronic fatigue syndrome. Holly became so depressed that she started self-harming. She has stopped doing this, but her health has never recovered. Her mother says she's been a virtual prisoner in her home for two years.

How the risk/benefit stacks up

Only the fourteenth most common cancer, cervical cancer is relatively rare, affecting 1 in 11,111 women who have abnormal smears. Of these, only 1 in 33,000 will die. Compare these figures to the casualty rate of the HPV vaccine; 1 in 300 girls have a serious, life-threatening reaction and 1 in 30 suffer a potentially life-altering autoimmune reaction. The dangers of the prevention well outweigh the dangers of the disease.

The curious case of Couric

Katie Couric was the highest-paid media presenter in the US and was known as 'America's Darling'. In 2013, she ran a programme on ABC TV about girls who had been injured by the HPV vaccine. She was immediately attacked for being unscientific and for overemphasizing adverse reactions without talking about the vaccine's benefits. In her blog on the Huffington Post website, she said that some of the criticism was valid.

A follow-up programme was aired the following week, which featured only pro-vaccine advocates. Despite this, her show was suddenly axed a week later.

Even so, the battle continued to rage on Couric's website. More than 12,000 people left comments, including a thousand from pro-vaccine lawyer Dorit Reiss of the University of California Hastings College of the Law in San Francisco.

Strangely, it doesn't work the other way. In a separate broadcast about vaccines, there was a campaign to ensure that the 'anti-vaccine' campaigner, ex-model Jenny McCarthy, was not allowed to appear. Instead, Reiss and her colleagues from Voices For Vaccines enjoyed sole billing. Although Voices claims not to accept pharmaceutical funding, it is associated with The Task Force for Global Health-which does.

References

1 J Inorg Biochem, 2012; 117: 85-92
2 Paediatrics, 2015; 135: e1131-40
3 Presentation at the AACR (American Association for Cancer Research) Annual Meeting, 19 April 2015, Philadelphia, Pennsylvania
4 Principes de Sant'e [Health Principles], 2014; 66: 16-8
5 BMJ, 2013; 347: f5906


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