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Gardasil

MagazineSeptember 2012 (Vol. 23 Issue 6)Gardasil

Where the US leads, the UK follows, and vaccines are no exception

Where the US leads, the UK follows, and vaccines are no exception.

The UK just announced that it is replacing the Cervarix vaccine, its current vaccine, with Gardasil, the vaccine supplied for America, during a new stepped-up campaign to combat cervical cancer starting in September.

Gardasil, manufactured by Sanofi and Merck Sharp & Dohme (MSD), is touted as preventing infection from four strains of the human papillomavirus (HPV), which can cause cervical and vulval precancers and genital warts. Consequently, the vaccine is supposed to protect against these HPV strains as well as genital warts, compared with GlaxoSmithKline's Cervarix, with its more modest claim of protecting against only just two types of HPV strains.

GlaxoSmithKline, which has supplied Cervarix to the UK since the launch of the campaign in 2008, claims that it didn't take part in the latest 'tendering' exercise to provide a vaccine for the UK's programme because the UK government announced that it wanted to protect girls against genital warts as well as all of the types of HPV that cause cervical cancer.

With the prevention of anal warts as its big selling point, Sanofi and Merck have come to realize that Gardasil is a unisex vaccine and are now targeting the market for teenaged boys in the US, with the UK again soon to follow suit.

Guarded secrets
What the UK government isn't telling teenagers-or their parents-is that both vaccines come with a big downside: a growing body count on both sides of the Atlantic.

The website truthaboutgardasil.org, set up by mothers of teenaged victims of the vaccine, claim that more than a 100 girls have died in the US alone from the vaccine and thousands more suffered side-effects.

Serious adverse reactions have included deaths, convulsions, paralysis, seizures and stroke, Guillain-Barr'e syndrome, autoimmune disorders, chronic fatigue, muscle and joint pain and weakness, deep vein thrombosis, pulmonary embolisms, anaphylaxic shock and . . . believe it or not, cervical cancer.

In a report entitled 'Gardasil Post-Licensure Pediatric Safety and Adverse Event Review', covering just the two years between October 2009 and December 2011, the US Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS) recorded 14 'official deaths' and 818 'serious' events (which included death, plus life-threatening experiences, in-patient hospitalization, prolonged hospitalization or persistent disability) among girls and young women aged nine to 26 years, as reported from the US and other countries. Among young men in the same age range, there were 10 deaths and 80 serious events.

It's as well to bear in mind that these figures are most likely extraordinarily low; the VAERS reporting system only receives an estimated 10 per cent of all vaccine side-effects reports, which means that the serious side-effects could be closer to more than 9000 over the past two years alone.

Furthermore, although the vaccine was fast-tracked through the system in six months, the FDA has recently recommended asking for a label change noting the possibility of syncope (fainting), venous thrombotic events (VTEs) and autoimmune disorders. The agency has also launched its own study of VTEs and Gardasil.

These and other effects may have to do with a new syndrome seen with vaccines like the HPV called 'immunotoxicity'. Several years ago, the FDA's Center for Drug Evaluation and Research identified numerous problems associated with overstimulation of the immune system, including cell and tissue abnormalities and injury, 'cytokine storm' (overstimulated cytokine release) and tumour lysis syndrome, a metabolic disorder causing the breakdown of cellular DNA, and autoimmune problems (J Immunotoxicol, 2008; 5: 33-41).

Although there is no official side-effects count in the UK, there are several websites devoted to injuries, deaths and 'mystery illnesses' related to Cervarix.

Marketing manoeuvres
As with vaccine drives in the past, the UK's latest campaign may represent a cynical move by Merck to shift stocks of a vaccine that has been a relative market flop following an effective campaign by parents of damaged children to inform the public of the dangers and lack of effectiveness of the vaccine. Gardasil represented the pharmaceutical company's Great White Hope after the disastrous lawsuits connected with its discredited arthritis drug Vioxx, responsible for tens of thousands of deaths for which Merck paid out a $1 billion settlement.

Merck's Gardasil had an explosive initial start, with sales reaching a worldwide healthy $1.5 billion soon after the vaccine was launched in 2006, following an aggressive marketing campaign running television commercials all over America aimed at 13-year-olds. The marketing of Gardasil represented the drug industry's first direct-to-teenager advertising campaign.

In Europe, Sanofi Pasteur followed this creative lead by organizing a mass rally in Paris lasting one week in 2007, which included leading doctors from all over Europe sharing the platform with celebs and demanding the universal take-up of Gardasil.

The only snag was that the rally and support campaign were funded entirely by Sanofi which, by 2007, had paid out some lb1 million ($1.9 million) to get their new vaccine adopted by governments around the world. In fact, they even underwrote the travel expenses of most of the 'guests' attending the Paris rally as "the first global summit against cervical cancer". Some partici-pants even received a fee for attending.

This huge marketing effort badly backfired after the first casualties started appearing, and parents began setting up powerful websites around the world, revealing the evidence to date about the vaccine.

By 2010, sales had fallen by one-third. Merck suffered an even bigger blow in the autumn of 2011, when the vaccine got caught in the Republican presidential candidate crossfire.

After Texas Governor Rick Perry, the first politician mandating Gardasil use in his state, was discovered to have ties to Merck, one of his rivals, Representative Michele Bachmann, attacked his position by announcing on national TV that the vaccine was dangerous and that she'd met a mother whose daughter had become "mentally retarded" after being given the shot.

All of these events has meant that Gardasil's take-up rate now amounts to only about one-third of all eligible girls in the US.

Recently, the United Nations Population Fund and Sanrio, the manufacturer of the global 'Hello Kitty' brand, have collectively launched a campaign called the 'Hellosmile Project'.

The idea is to use the saccharin little cat to raise awareness globally of the need to prevent cervical cancer. Although it originated in Japan, the campaign has recently reached American shores through the recently revamped high-end Hello Kitty store in Times Square in New York City.

The truth about Gardasil
What has got lost in all of this dizzying flurry of PR and product placement is that Gardasil does not actually prevent cervical cancer, but only sometimes prevents that nebulous condition referred to as 'precancer'.

Gardasil was indeed the first vaccine to show that it can prevent four strains of HPV, considered to be among the leading causes of precancerous cervical conditions and cervical cancer itself.

Nevertheless, of the more than 100 strains of HPV, only 40 are known to cause genital infections and half of those are proven to cause cancer, with some causing genital warts. The vaccine purports to prevent infection by HPV strains 6, 11, 16 and 18. According to Merck's product site, HPV types 16 and 18 cause 70 per cent of all cervical cancer cases, while types 6 and 11 cause 90 per cent of all cases of genital warts.

This means that the vaccine only claims to prevent a person from being infected with just those few HPV strains, but not to prevent cancer from developing once you are infected.

Furthermore, the vaccine only works so long as the individual has never been exposed to HPV before-which is why Merck is targeting young women before they become sexually active.

Despite the best efforts of Merck, Sanofi and now Hello Kitty, cervical cancer isn't the big killer they'd like to make it out to be. Of all new cases of cancer, cervical cancer doesn't even make the top 10. In the UK, about 2700 cases are discovered every year, placing it at well only half the incidence of the 10th most common cancer, leukaemia, and far behind breast, lung, colorectal and uterine cancers, non-Hodgkin's lymph-omas, melanomas, and thyroid, ovarian and kidney cancers.

Considering the numbers of young women who have been injured or killed by the vaccine, it's a moot point as to whether more are harmed by the disease itself or its so-called 'prevention'.

Lynne McTaggart

WDDTY vol. 23 no.6


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