Gardasil: Selling out our children

Besides Katy Perry’s song I Kissed a Girl, 13-year-old American girls now have a new anthem. It’s the ungrammatical “I want to be one less”, and there are commercials all over American television showing preteens writing ‘one less’ on their gym shoes, appliquéing it onto their hoodies and even chanting it like a mantra in time to jumping rope—“One less, one less, one less!” 

‘One less’ refers to the one less young woman who will have to battle cervical cancer, and it is the drug industry’s first direct-to-teenager advertising campaign launched to sell Gardasil, the first vaccine purporting to prevent cervical cancer. 

In the US, where Gardasil has been available for the past 18 months, 41 of the 50 American states have now introduced legislation concerning cervical cancer and the human pap-illomavirus (HPV) vaccine, and 24 states are attempting to enact laws to make having the vaccine a pre-requisite for starting school among preteenagers. New reports show that, so far, one in four teens has received the new vaccine.

Now, the UK has just kicked off its own countrywide programme of vaccination this autumn, targeting all young girls between ages 12 and 13 as part of its vaccination schedule. In April 2008, the Scottish govern-ment announced ambitious plans to vaccinate all girls aged under 18.

Indeed, Merck—Gardasil’s manu-facturer—has its sights set on many other countries around the world.

And now that cancer has replaced heart disease as the number-one killer in the West, the first vaccine against cancer has been greeted with open arms.   

The impeccable timing and high-profile coverage of television’s Big Brother star Jade Goody’s diagnosis of stage III cervical cancer has also served to heighten fears concerning the dangers of sexually transmitted cancer in the minds of British women.

 

Selling fear for profit

In fact, the selling of Gardasil is the story of the most cynical drug-company salvo yet—an expensive marketing campaign designed to spread fear among a generation of young women simply to market a dubious, untested, ineffective and possibly dangerous solution to a relatively rare and highly treatable cancer.

In the scant two years since Gardasil’s launch in 2006, the US Food and Drug Administration (FDA) has already received nearly 9000 reports of adverse events for this vaccine alone—including at least 10 deaths within the past year and a possible 20 deaths in total. This means that hundreds of girls and young women are being hospitalized, left permanently disabled or under-going a slow, long-term recovery as a result of having received this vaccine. A number of them are suffering from Guillain–Barré paralysis, and many of the deaths were due to heart attacks or blood clots. 

What’s worse, as these are only the cases reported to the US Vaccine Adverse Event Reporting System (VAERS), known to attract only some 10 per cent of all cases, the true tally of victims is likely to be far higher.

Given such carnage so early in a vaccine’s history, it becomes clear that the important questions to be asked with each and every jab are: How necessary is it, how effective is it and, most important of all, how safe is it?

 

Not cancer, just ‘precancer’

First of all, it is important to recognize that this vaccine has not been proven to prevent cancer, but only that nebulous condition referred to as ‘precancer’.

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

Yet, of the more than 100 strains of HPV, only 40 are known to cause genital infections and half of those proven to cause cancer, with some causing genital warts. The vaccine purports to prevent infection by 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’s being infected with those few HPV strains, but not to prevent cancer from developing once you are infected. It also apparently 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.

 

One in two

There’s no doubt that HPV infection is rampant across the globe. Accord-ing to the US Centers for Disease Control and Prevention (CDC), as much as 50 per cent of sexually active men and women become infected with HPV at some point in their lives. Because the virus is so pervasive, by age 50, at least 80 per cent of women will have acquired genital HPV infection.

In America, this translates to some 20 million Americans who are currently infected with HPV. And another 6.2 million, on average, are newly infected each year, according to the latest CDC figures.

Nevertheless, says the CDC, in the overwhelming majority of instances, the body’s immune system is able to fight off HPV naturally, so that the infected cells revert to normal. Only in cases where the immune system doesn’t win and the infection lingers for many years can the virus then turn abnormal cells into cancer.

 

Not in the top 10

According to the American Cancer Society, of the more than 270,000 women who will die of cancer in the US this year, lung and bronchial cancers are the leading causes of cancer deaths, accounting for 26 per cent of such deaths, followed by breast cancer, which is responsible for 15 per cent of deaths, then colon and rectal cancers, pancreatic cancer, ovarian cancer, leukaemia, non-Hodgkin’s lymphoma, uterine cancer, brain and other nervous system cancers, and liver cancer.

Of all new cases of cancer, cervical cancer doesn’t make the top 10 either. The incidence of cervical cancer represents only about half the number of cases per year of the 10th most common cancer—leukaemia—and falls well behind breast, lung, colorectal and uterine cancers, non-Hodgkin’s lymphomas and melano-mas, and thyroid, ovarian and kidney cancers.

The American Cancer Society estimates that, by the end of 2008, 11,070 women will have been diag-nosed with cervical cancer in the US, and another 11,990 individuals will fall victim to another form of HPV-related cancer of the genitals. 

This can be compared with the approximately 215,000 cases of breast cancer that occur annually among American women. One in eight US women get breast cancer at some point in their lives. This means that women in America are at least 20 times more likely to have breast cancer than cervical cancer.

So, what does this all mean? Of the 26.2 million people with HPV infections, the chances of developing any sort of  cancer related to HPV in any given year are 0.08 per cent, and the chances of getting cervical cancer are 0.04 per cent—in other words, out of every 10,000 people with HPV, four will progress to cervical cancer. To put this in perspective, the chances of getting cervical cancer due to HPV infection in any given year are eight times greater than your risk of being struck and killed by an asteroid or about the same as being fatally electrocuted. 

Cervical cancer appears to be a disease of malnutrition and environ-ment. It is the second most common cancer in the developing countries, and was once a major killer among American women, but has declined by 75 per cent since 1992. The death rate due to this cancer continues to fall by 4 per cent every year. 

Indeed, according to the American Cancer Society, an average of 71.3 per cent of all women with cervical cancer survive, with higher survival rates among whites (72.9 per cent) than in blacks (60.4 per cent), suggesting that the main determin-ant for survival is lifestyle, including having access to the means for early detection.

So, of those 11,070 women who fall victim to cervical cancer each year in the US, 7893 will survive it, leaving a relatively tiny annual death toll of 3177 women.

Nevertheless, it may be worth putting a generation of 12-year-old girls at risk to save 3000 of their lives later on as adults—but only if it could be shown that HPV were responsible for all those cancer cases, and if the vaccine could target and prevent them, a situation that is by no means certain.

 

A tiny per cent of a tiny per cent

As the US National Institutes of Health (NIH) is at pains to point out, HPV does not lead directly to cervical cancer.  Rather, the virus can cause cell abnormalities, or dysplasia, and it is this state that may, over time, develop into cancer.

There are four categories of abnor-mal, or ‘precancerous’, cells found in cervical lesions: they are referred to as ‘cervical interstitial neoplasia’ or CIN 1, 2 and 3, and then cancer. At this time, medicine has no way of determining which of these early-stage abnormalities (CIN 1 or 2) is likely to progress to cancer. In fact, according to the evidence, some lesions regress even when left alone while others will progress rapidly. However, what is known is that only 1.6 out of every 1000 women who have abnormal smears will go on to develop cervical cancer (Lancet, 1993; 342: 91–6).

In the majority of cases in the US, CIN 2 develop into true invasive cancer only 5 per cent of the time. Even CIN 3—the most advanced of the ‘precancerous’ conditions—leads to cancer in only 12 per cent of patients (J Clin Pathol, 1998; 51: 96–103).

 

How effective is the vaccine?

In a pre-release drug trial carried out by Dartmouth Medical School in New Hampshire—sponsored by Glaxo-SmithKline—the HPV vaccine was claimed to be 100-per-cent effective in stopping persistent HPV infection by types 16 and 18 (Lancet, 2004; 364: 1757–65). However, the entire trial and follow-up had lasted for only up to 27 months.

The results of longer-term (three years on average) studies were only published after the vaccine had been approved. These trials—referred to as FUTURE (Females United To Unilaterally Reduce Endo-ectocer-vical Disease) I and II—were publish-ed simultaneously and back-to-back in the 10 May 2007 issue of the New England Journal of Medicine (N Engl J Med, 2007; 356: 1915–27; 1928–43).   

FUTURE I showed only a 20 per cent effectiveness, mostly in cases of CIN stage 1—the type that generally goes away by itself. FUTURE II combined four placebo controlled trials, involving a total of 20,583 women who had been given the vaccine against four HPV strains, two strains or a placebo. Although the study claimed to find a 99-per-cent efficacy, the overall reduction of the incidence of all stage 2 and 3 cervical lesions or actual cervical cancer from these strains was only 18 per cent (Lancet, 2007; 369; 1861–8).

In fact, FUTURE II showed virtual-ly no evidence that the vaccine could provide any substantial protection against CIN 3—the lesions that are most likely to progress to cancer. All that the vaccine can do is prevent a small percentage of CIN 2 lesions, which are responsible for only 5 per cent of invasive cancers.

In yet another multicentre study —the HPV PATRICIA (Papilloma Trial against Cancer in Young Adults)—efficacy was not significant against HPV-18 alone (Lancet, 2007; 369: 2161–70).

It is essential, given these data, to do the math. If the vaccine can only successfully prevent those abnormal lesions that turn into cancer in just 5 per cent of cases, and there are 11,020 cases and 3177 deaths in any given year, the vaccine prevents—at best—553.5 cases of cancer and 159 deaths in the whole of the US every year.

However, this tiny advantage is more than wiped out by the cost in young human lives: at the very least, 4500 girls every year will go on to suffer serious side-effects—including at least 10 that will be fatal.

 

New cancer from the vaccine

As with many other vaccines, such as the Haemophilus influenzae type b vaccine, targeting one virus often leads to an imbalance in the viral population, causing others to proliferate. Several studies have shown that protecting women against HPV types 16 and 18 can lead to an increase of other HPV-associated dysplasias that lead to cancer. In addition, a number of studies have shown evidence of cancerous lesions caused by strains other than HPV-16 or HPV-18.

The FUTURE II trial found that non-vaccine HPV types contributed to a sizeable number of grade 2 or 3 CIN lesions. In fact, after they’d worked out all of their statistics, they found that the incidence of CIN disease had increased, regardless of HPV type, suggesting that other HPV types had filled the vacuum left by the eradication of the small per-centage of vaccine types 16 and 18. Indeed, the interim evidence handed to the FDA showed that the cases of CIN 2 or 3 due to HPV types not covered by the vaccine had increased among those women who had been vaccinated (see the FDA review of the Gardasil license applications at www.fda.gov/OHRMS/DOCKETS/ ac/06/slides/2006-4222S-2_files/ frame.htm).

The HPV PATRICIA study also found a high proportion of lesions caused by other non-vaccine-covered HPV types (Lancet, 2007; 369: 2161–70).

 

Never tested in young girls

Nevertheless, these dubious benefits only apply to the 15- to 25-year-olds who were included in these studies.

The most astonishing revelation of all is that the vaccine has never been truly tested in girls 12–13 years of age—the very population being stuck with the vaccine.

Every major study of this vaccine has been carried out on women aged between 15 or 16 and 24 years. The effect on 12-year-olds has been ‘inferred’ from the fact that: (1) young girls given the vaccine show high blood levels of antibodies; (2) the vaccine appears to prevent infection by the targeted strains in those who have never been exposed to HPV; and (3) it doesn’t work as well in women who are sexually active.

We also don’t know how long the vaccine coverage lasts. If girls are being given the vaccine so many years before they are likely to be exposed to HPV, will it have worn off by the time they are in their 20s and more likely to need it?

 

How safe is the vaccine?

Aside from possibly encouraging other cancer-causing virus types to flourish, the vaccine has been linked to a host of other side-effects. According to the US VAERS, there have been at least 20 deaths, 204 hospitalizations and 124 girls left disabled. Judicial Watch in America discovered 140 serious reports (27 characterized as ‘life-threatening’), 10 spontaneous abortions and six cases of Guillain–Barré syndrome in the first five months of 2008. Other adverse events include: disorders of the lymphatic system; nervous sys-tem disorders such as seizures, dizziness, headache and Guillain– Barré paralysis; joint and muscle pain; anaphylactic shock; and bronchospasm. 

These and other effects may have to do with a new syndrome seen with vaccines like the HPV called ‘immunotoxicity’.  In 2006, the FDA Center for Drug Evaluation and Research organized an Immuno-toxicology IV meeting with a group of vaccine company executives to examine this novel form of toxic response. The group 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 Immuno-toxicol, 2008; 5: 33–41).

Besides damaging young girls, Gardasil can cause congenital dis-orders in women who are pregnant when they receive the vaccination. Among the women participating in the FUTURE studies who became pregnant within 30 days of the vaccination, five cases of congenital abnormalities were observed in the women given Gardasil compared with none among those given a placebo.

These birth defects included pyloric stenosis (affecting the stom-ach and intestine), congenital mega-colon, congenital hydronephrosis (affecting the kidney), hip dysplasia and club foot. In addition, more of the vaccinated nursing mothers had children with respiratory distress than those who received a placebo.

In the light of the shoddy evidence behind this vaccine, every day that this drug is given, we’ll see ‘one less’ healthy teenager.

Lynne McTaggart

 

First invent the problem . . .

  How did Merck instill in the public mind the idea that cervical cancer is one of our most pressing cancer problems? As one adman once famously said, “Invent the problem to sell the solution.”

So Merck hired public-relations monolith Edelman, the world’s largest independent PR firm and a favourite among the drug company fraternity, to ‘sell’ the concept of cervical cancer as a pervasive killer through a cleverly staged series of direct-to-consumer advertisements and commercials.

Merck spent an estimated $841,000 for Internet ads in a single quarter of 2006 alone. In addition, in the two months prior to FDA approval of Gardasil in June 2006, the company had paid for more than 1000 television commercials.

The first prong of Merck’s vast budget was used to create a buzz on the dangers of the human papilloma-virus (HPV) in American women a whole year before the vaccine was even released. In 2005, Merck funded a national campaign called Make the Connection, paying for TV spots and print ads in the women’s press, and enlisting celebrities such as Courteney Cox, Geena Davis and Brooke Shields to sport Make the Connection bracelets to make the link between HPV and cancer. 

Merck then moved into its second phase—called Make the Commitment—urging women to demand Gardasil from their doctors when the FDA approved the drug and made it available. This had the effect of creating a huge demand for the drug even before it was on the market.

Merck then funded a series of Tell Someone commercials, with actors playing ordinary women who were shocked to learn that HPV is not only so prevalent—infecting millions of women—but also a cause of cancer. The actors conveyed a sense of urgency to follow the slogan on the tee-shirts they were wearing—to ‘tell someone’ they know all about this silent looming epidemic.

Once the vaccine was approved, Merck began its direct-to-preteenager campaign: One Less. The most notable aspect of these commercials is that they show young girls telling their peers—rather than their parents—about their intentions to be ‘one less’ . . . and with good reason.

In the US, although parental consent is required, girls are now allowed to overrule their parents if they wish to be vaccinated. Little wonder that the drug giant has sought to instil in the minds of young girls both the fear and the resolve to do something, even if it means going against the wishes of Mom and Dad.

 

Follow the money

  So why did Merck, the vaccine’s manufacturer, rush this product out?

At this juncture, Merck needs the money. Merck is still smarting from the Vioxx scandal of three years ago, when it was discovered that the pharmaceutical giant had launched an aggressive marketing campaign for the arthritis pain-reliever in the full knowledge that the drug could cause an increase in heart attacks. Vioxx is believed to have caused heart attacks in some 60,000 patients worldwide. 

The drug’s eventual recall cost Merck an estimated $2.5 billion a year in lost revenues. The Big Pharma giant then had to put aside $1.64 billion for legal costs alone in what became the biggest civil lawsuit in history: 27,000 lawsuits involving some 46,000 patient groups in federal courts and at least seven state courts, plus at least 266 class-action lawsuits alleging personal injury and economic loss. Eventually, the company threw in the towel and paid out a massive $4.85 billion settlement, now expected to benefit 50,000 patients or their families.

Gardasil is formulated to be given in a series of three injections, costing a total of $360. 

Creating a product designed to be given to half of all Western teenagers and then to be distributed widely throughout the developing countries clearly amounts to a license to print money. Gardasil’s global market value for the first three years of its life has already been estimated to be around $2–4 billion.

 

How to prevent cervical cancer

  Given the enormous disparity between the incidence of cervical cancer in the developed West and developing countries, cervical cancer is very likely a lifestyle disease. It appears to be rampant in regions of poor sanitation and nutrition. In the vast majority of people with a healthy lifestyle, the immune system alone can easily overcome the human papillomavirus (HPV). This means that the best defense against HPV is to follow these simple rules:

-           Eat a healthy, wholefood organic diet

-            Encourage your daughters to practice abstinence and, when they are older, to stay in a committed relationship

-           Use barrier methods of contraception. Although there is disagreement as to whether or not condoms protect against HPV, they can protect against other sexually transmitted diseases

-           Avoid oestrogen overload, which is linked to cervical cancer. This includes avoiding the Pill and hormone replacement therapy (HRT)

-           Filter your drinking water, which contains many oestrogens from chemicals

-           Avoid drinking from plastic bottles, which contains phthalates, which are also oestrogen mimics

-           Eat a diet rich in raw cruciferous vegetables, such as broccoli, cauli-flower, cabbage and brussels sprouts. These contain indole-3-carbinol (I3C), transformed in the body into di-indollyl methane (DIM), which blocks many toxic forms of oestrogen and has been shown to reduce the incidence of cervical dysplasia. Cooking inactivates I3C, so eat these veggies raw or fermented, as in sauerkraut

-           Take DIM supplements if you have a history of oestrogen-related cancer in your family.