Gardasil: Fast-Tracked and Flawed

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Carolyn Moynihan | Aug 22 2017

The Australian government is likely to provide a new version of the vaccine that is said to prevent cancer soon. Gardasil 9 would replace the original Gardasil — administered to young high school students in three doses – with a two-dose regime involving a stronger formula that is already used in New Zealand and the United States. The vaccine promises protection against the human papillomavirus (HPV), certain strains of which, it is generally accepted, can cause cervical cancer.

Like the original roll-out of the drug 10 years ago and promotions since, this one is being heralded by very optimistic messages: “New cervical cancer vaccine may almost eliminate disease, research shows,” ran a recent headline. “It’s truly ground-breaking,” the scientist who led the new research, Professor Julia Brotherton, told the ABC. “The possibility that we can now prevent our children being infected with this cancer-causing virus, I just think that’s amazing.”

But not everybody is so happy about Gardasil. In addition to the anti-vaccine camp, there are parents, women’s health activists and some doctors who question the way it was hustled into national health systems, its safety, and its claims.

One dissenter is Helen Lobato, author of an expose published recently by Australian feminist publisher Spinifex. In her introduction to Gardasil: Fast-Tracked and Flawed she says:

“Fast-tracked and poorly tested vaccines are now given to young girls and boys because of a link between the human papilloma virus and cervical cancer. … [T]hese vaccines are not only unproven but the vaccinated girls and boys can suffer devastating adverse effects that result in permanent ill-health and even death for some of them.”

Lobato, a former nurse, had her own brush with cervical cancer in 1985. This gives her a personal stake in the representation of the disease today. Like many other women, she may have been saved from full-blown cervical cancer by having a Pap smear (a test that dates back to the 1940s and has been offered through national screening programmes in more recent decades) that allowed timely (if somewhat brutal, in her experience) treatment for a pre-cancerous condition.

In fact, the effectiveness of cervical screening is a key argument in her case against the HPV vaccine. Others are: it was rushed onto the market after inadequate trials; it is associated with thousands of adverse reactions and some deaths; it is administered without adequate informed consent; there is no proof that it can prevent cervical cancer.

Is this vaccine really necessary?

When a lay person considers a vaccine they think in terms of being protected against a widespread contagious disease. HPV is, apparently, such a disease. It is said that around 80 percent of people who have sex at all will get this infection at some stage. But we are also told that 90 percent of the infections will clear within a year. So why vaccinate as many girls and boys as possible against it? Because 10 percent may be at risk of cancer?

But the incidence of cervical cancer in countries like Australia is nothing like 10 percent. It is less than 1 percent, Lobato reports. (P 81) There is no epidemic of cervical cancer in any developed country (it is a different story in developing countries).

Moreover deaths from this cancer in Western countries is even rarer – at the rate of 1.7 per 100,000 women in Australia, which in 2014 amounted to 223 deaths from the disease — compared with 2,844 deaths from breast cancer (a figure which is expected to rise). Cervical screening is said to have halved the number of deaths since 1991, though Lobato believes that improvements in living standards played a part.

Her reading of the history of the disease suggests that poverty (including poor nutrition and hygiene) played a large part in earlier times, and more recently the contraceptive pill (its effect on immunity), smoking and other lifestyle factors. She discounts early theories that linked cervical cancer to “sexual excesses and immorality” and regrets that the current focus on HPV has swung the pendulum back in this direction.

The race to provide a vaccine

The hypothesis that HPV and cervical cancer are linked goes back several decades, and the idea of a vaccine against the STD was first mooted in the 1970s. Research began in several centres but in the end it was an Australian team – Scottish-born Professor Ian Frazer, and Dr Jian Zhou, at the University of Queensland – that made the breakthrough by producing a synthetic version of the HPV virus in 1991.

From the late 1990s in Australia and internationally, Lobato says, “a relentless propaganda campaign” for the vaccine began to build. This reached its peak in 2006, when Frazer was hailed as a national hero (Zhou died in 1999) and he personally vaccinated the first woman at the Sydney launch. There were 947 pieces of media devoted to the Australian campaign, driven by PR giant Edelman.

US television hosts hailed the vaccine as “a triumph in science and medicine” and something that “could save your teenager’s life someday”. Based on a US television advertisement featuring health young girls, “One less” (victim of cervical cancer) became an international slogan – as though victims were dropping like flies.

“Gardasil was fast-tracked through the FDA [the US Food and Drug Administration], a process usually reserved for life threatening diseases to fill an unmet and urgent medical need,” says Lobato. For her, this was a coup for Big Pharma rather than women or even public health. The drug companies, which funded the trials, stood to gain huge revenues.

In November 2006 the vaccine was listed on Australia’s national immunisation register and on International Women’s Day 2007 the program was launched.

The vaccine is provided free through schools to girls aged 12 and 13, and to boys on the same basis since 2013. Up till now, three injections are given over six months. And yet Gardasil had been tested on fewer than 1200 girls under the age of 16 when the national program began. Cervarix, the other brand used in Australia and Europe, was also studied in a small number of young girls.

Lobato quotes Diane Harper, one of Merck’s HPV vaccine researchers “and now a whistleblower,” saying that the roll-out “went too fast, without any breaks.”

Adverse reactions, deaths: what’s in Gardasil?

That was in 2008 and Harper was commenting on the mounting toll of side effects being reported – the dominant concern of Lobato’s book. It begins with the case of Australian woman Krisitn Clulow, who received her first two shots of Gardasil in May and August 2008 and whose health thereafter collapsed owing to an inflammatory disease of the brain. With treatment she recovered by 2010. A homeopath who helped her recovery informed her that her body was high in aluminium.

“Aluminium is a neurotoxin,” says Lobato, and each dose of Gardasil contains 225 micrograms of it as an adjuvant – a booster of the essential ingredient. Gardasil 9, approved by the FDA in 2014 for the prevention of cervical, vulvar, vaginal and anal cancers will contain 500mcg of aluminium and a larger dose of antigens (the HPV LI proteins). Cervarix also contains the chemical in the form of aluminium hydroxide.

Lobato regards this as a major reason that “HPV vaccines are associated with more deaths, and serious adverse effects than other vaccines.” According to the World Health Organisation’s Vigibase, there are now over 73,000 recorded adverse events after HPV vaccination. Lobato says there have also been at least 324 deaths.

All vaccines have side effects, but the fact that an illness or death occurred after vaccination is not proof that it was caused by the vaccine. Also, the plausibility of the case against the HPV vaccine is influenced by one’s attitude to vaccines in general, and Lobato seems to lean to the anti-vaccination camp.

Nevertheless, the National Vaccine Information Center in the US published a Gardasil risk report in 2009 which found that death and serious adverse events are reported three to 30 times more often after Gardasil than after the meningococcal vaccination Menactra.

This data needs scientific study, but it will be difficult for interested scientists to get funding for such research in the current climate. Australian GP Deirdre Little has documented in medical journals three cases of premature ovarian failure (early menopause) in adolescent girls who had been vaccinated with Gardasil, and she has questions about the vaccine’s safety – and the manufacturer’s research — from that point of view.

No proof that HPV vaccination prevents cancer

“We can now prevent cancer.” Lobato says there is no proof that this is the case. This is because HPV vaccines have never been tested against cervical cancer outcomes only against surrogate endpoints: cervical intra-epithelial neoplasia (CIN) garde 2/3 lesions, and carcinoma in situ. These precursor lesions are common in women under 25 but rarely progress to cancer, according to Lobato.

To have allowed human test subjects to progress towards cancer in order to prove its efficacy at that point would be unethical, so there is nothing wrong with using surrogate endpoints, but the claims should be correspondingly modest. Instead, public messaging has harped on the cancer prevention potential of the vaccine – really, to maximise the number of young people receiving it. Basically, those young people are part of an experiment. A good experiment, perhaps, but shouldn’t parents and the wider public be informed that it has a downside?

Lobato concludes her book with an appeal to the media to do their job and give the public the fuller story about the HPV vaccine. You may not agree with her version of the story at all points, but she has shown Big Media some of the things they could be airing in the interests of informed debate.

Carolyn Moynihan is deputy editor of MercatorNet.

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