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HPV vaccine on trial – the making of another drug tragedy, Part 1

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Sally Beck has been investigating the HPV vaccine since it was introduced; here she serialises sections of a new book called The HPV Vaccine on Trial by Mary Holland, Kim Mack Rosenberg and and Eileen Iorio. Since its authorisation in 2006, Merck’s HPV vaccine has left thousands of girls and women damaged or incapacitated. Part 1 covers the background to its introduction and what happened to two of the girls on whom it was tested in Europe.

MORE than 270million doses of the human papilloma virus vaccine have been administered in over 125 countries worldwide since it was introduced in 2006. It was supposed to prevent cervical cancer but instead we have yet another emerging scandal with manufacturers and drug regulators doing their best to suppress the evidence.

The late Nobel Prize winner Luc Montagnier, who discovered the HIV virus, said of the HPV: ‘The side effects are underreported by medical personnel, while there are a growing number of parents suing manufacturers and governments for inducing lifelong handicaps, even death, of their loved ones.’

The percentage of adverse events reported to the Vaccine Adverse Event Reporting system (VAERS), in the US between 2007 and 2013 represented between 42 per cent and 80 per cent of adverse events for all vaccines administered to females aged nine to 29. Following its introduction to the UK in 2008, our Medicines and Healthcare products Regulatory Agency (MHRA) has received 4,000 reports of serious adverse reactions.

Sadly, the UK has yet to sue on behalf of injured women here, but lawsuits have now been filed by many countries including the US, India, Colombia, Japan, Spain, and France against government health agencies, and the two manufacturing companies Merck and GlaxoSmithKline (GSK). Despite this, boys and girls as young as nine still receive the HPV in the US, and from age 11 to 26 in the UK.

A new book, The HPV Vaccine on Trial, makes it clear that trial participants were lied to and the results were skewed. Women who volunteered to take part were told they would receive a saline placebo. In fact it was a ‘fauxcebo’, a potentially toxic aluminium adjuvant that could cause devastating side effects.

Merck hoped the HPV vaccine, Gardasil, would distract from its expensive Vioxx scandal and replenish its coffers. Vioxx, a painkiller, provided it with $2.5billion (£2.04billion) in revenue, but its side effects caused heart attacks, strokes and death. Merck was showered with 24,000 lawsuits and entered a $4.85billion (£3.96billion) settlement with injured plaintiffs. The HPV vaccine, supposed to be a blockbuster drug, was dubbed ‘Help Pay for Vioxx’. Now Merck is being investigated for making false marketing claims, failing to disclose material information to consumers, and more.

The most affecting stories come from two young Danish women who volunteered to take part in what should have been a double-blind placebo-controlled trial – but there was no saline placebo.

Kesia Lyng was 18 and still at school when she received a brochure in the mail inviting her to join the trial. It said the vaccine had no side effects as it had already been thoroughly tested, and that half of the participants would receive saline – a trial protocol recommended by the World Health Organization (WHO).

Six months earlier, her beloved grandmother had died of cervical cancer at 68. Kesia wanted to help prevent others suffering such a loss and although her worried parents discouraged her, Kesia was determined.

She had her first shot in 2002. It hurt, a lot. Later that day she felt tired, her arm was weak and she felt disconnected. Kesia had her second shot two months later. After this she developed flu-like symptoms, muscle pains, and for most of the week felt like her head was in a vice. Then, for the first time, she had trouble sleeping. Exhausted, it took her hours to drift off and she awoke every hour, as she would do for the next 14 years.

Kesia remembers her third appointment vividly. The corridor looked long, and she walked slowly. She told the trial nurse she wasn’t feeling well, was tired and in pain, and about the headaches that lasted all day. The nurse said not to worry, some headaches were normal.

Reluctantly, she took the third shot. She felt dizzy, nauseous and her arm hurt even more. Kesia went to see her GP, who was concerned enough to put a double exclamation mark in her notes next to details about the trial. Trial staff simply said these were not the symptoms they would expect to see after the vaccine and Kesia had no reason to disbelieve them.

However, she became so ill that she missed exams and was unable to graduate from school. She could not get through the day without headache or pain in her joints and muscles. It was a struggle to get out of bed. She had wanted to study as an interior designer or window dresser in Copenhagen. Instead, she lost count of doctors’ visits; they could never find a reason for her pain and fatigue.

Kesia struggled on, married and had two children, and in 2007 learned she had not had the placebo. 

Then she met Sesilje (pronounced Cecelia) who had been in the same trial. Their stories were remarkably similar, but Sesilje had received the placebo.

She was a 21-year-old undergraduate at the time who was also told the vaccine was safe. Her first shot was painful, and she had an unusual menstrual period. After her second and third shots she experienced not just another heavy period; her skin hurt, she had headaches and flu-like symptoms. Her stomach hurt and she lost 12lb in two weeks. She developed allergies. She was baffled, so were her doctors. Trial staff said all symptoms were unrelated.

In 2007, she discovered she had received the placebo and her doctor found she had abnormal cervical cell growth. Trial staff put her under pressure to take the vaccine and she was more afraid of cancer than the jab, so she did. Her health plummeted and her other symptoms worsened.

Both women connected the dots after a controversial Danish documentary, The Vaccinated Girls, in 2015, shone a spotlight on many who suffered neurological symptoms following Gardasil injections.

Sesilje then read that Merck had used an aluminium solution as a control. A clinical researcher by now, she discovered there was no saline group and realised that the aluminium had caused her first symptoms, compounded by the jab.

Denmark’s trial investigators knew that the placebo was the adjuvant amorphous aluminium (a known neurotoxin) hydroxyphosphate sulphate (AAHS) and, inexplicably, did not object. The vaccine also included the potentially toxic components polysorbate 80, which crosses the blood brain barrier and is associated with health problems including infertility in men and women, and cardiac risk. Also sodium borate, a genetically modified yeast used in cleaning products and banned in food products by the US Food and Drink Administration (FDA) because of its risks, and L-histidine, an essential amino acid important for tissue repair and growth, blood cell production and the development of embryos and organs. There’s scant data on L-histidine in vaccines but it may cause the immune system to malfunction, attacking the body’s own L-histidine. Low L-histidine levels are associated with autoimmune disease, particularly rheumatoid arthritis.

So, how essential is the HPV jab? HPV infections are endemic throughout the world and 90 per cent of infections resolve within two years without intervention. Around 0.18 per cent progress to cervical cancer. In a press release the FDA said most HPV infections were neither serious nor life-threatening, they were ‘short-lived and not associated with cervical cancer’. It advised women to have regular cervical screening.

There was no health emergency, which means the vaccine should not have been fast-tracked, which it was in 2002. Instead there was an aggressive marketing campaign which induced fear and created a market out of thin air. Merck sold fear of cervical cancer, not the vaccine itself, to consumers. The vaccines do not prevent infections from all HPV types associated with cancer, and not all cervical cancer is associated with HPV.

Merck’s ‘One Less’ campaign urged girls and teens to be one less cervical cancer victim. It featured athletic girls and young women skateboarding, playing basketball, surfing, dancing and swimming while their mothers showered them with affection.

The ads conveyed that ‘good mothers vaccinate’ but said nothing about sex, how the virus was acquired, potential side effects from the vaccine, or safer alternatives for cervical cancer prevention. Now the FDA and the WHO have received over 100,000 reports of adverse events, including deaths, from around the world. Are we supposed to believe these are all unrelated coincidences?

Part 2 on Friday will turn to the vaccine’s unauthorised testing on tribal Indian girls in 2009-10 which has been claimed to have led to the deaths of seven of them. 

The HPV Vaccine on Trial  was written and researched by Children’s Health Defense legal expert Mary Holland, lawyer and advocate for autistic children Kim Mack Rosenberg, and vaccine safety advocate Eileen Iorio.

Read our previous articles on HPV vaccine injured here and here.

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Sally Beck
Sally Beck
Sally Beck is a freelance journalist with 30 years of experience in writing for national newspapers and magazines. She has reported on vaccines since the controversy began with the MMR in 1998.

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