HPV - Cervical Cancer Vaccine

[Guest guest]

>From: " jackie@jabs " <jackie@...>

http://www.jabs.org.uk

This article has just been published on the JABS website with thanks to

Suzanne .

HPV – Cervical Cancer Vaccine

15 September 2006

By Suzanne

Honesthuman.com

Next month the Joint Committee on Vaccination and Immunisation is set to

determine whether pre-adolescent girls in the U.K. will receive a vaccine

for a sexually transmitted disease at primary school.

The vaccine, Gardasil, marketed by Sanofi Pasteur MSD, was approved for use

in women by British authorities in July, and by the end of the year

GlaxoKline's version, Cervarix, is likely to be available. Both target

human papillomavirus (HPV), a virus transmitted exclusively by sexual

contact that in rare cases leads to cervical cancer.

Paralleling a similar debate in the United States, much of the controversy

about putting the vaccine on the childhood schedule has been about whether

doing so will give youngsters a false sense of safety and lure them into

promiscuous sex.

Yet in the process of engaging that discussion, we're not talking about

whether giving the vaccine to pre-adolescent girls makes sense in terms of

their overall health, the long-term safety of the vaccine or whether it

should be given in school -- all subjects much more controversial than news

coverage would have you believe.

HPV is not a virus a kid catches by sitting next to someone at school. It

is not spread by sharing juice boxes or trading germs on the bus.

That makes this vaccine completely different from the 10 others on the

U.K.'s childhood vaccination schedule.

This vaccine aims to protect people from a virus that is basically only

transmitted when a person engages in what amounts to optional behaviour.

HPV is not a public health threat in the same way, say, polio or measles

are. And that gives governments much less of a compelling interest to

mandate that children be vaccinated for it.

Let's put aside for the purposes of discussion the bizarrely controversial

notion that parents should be able to decide what enters their children's

body via injection, especially when that shot carries the risk of harm or

death.

HPV does not lurk in the air, in swimming pools or on playground equipment.

That makes the vaccine's public health credentials dubious at best.

Yes, 3,000 women in the U.K. contract cervical cancer every year, and a

third of them die. But just having HPV doesn't mean you're going to get

cancer. The U.S. Food and Drug Administration said as much in its press

release announcing the approval of Gardasil: " For most women, the body's

own defense system will clear the virus and infected women do not develop

related health problems. "

Estimates of the number of people with HPV vary wildly, but perhaps up to

80 percent of women in the United States, for example, are infected with

HPV at one time or another before they are 50. Yet given that high

incidence, the number of women who develop cervical cancer in the U.S. is

pretty low, about 10,000 cases each year. Pap smears usually catch abnormal

cells before cancer has progressed, when women are treated with

extraordinarily high rates of success.

The greatest risk factor for cervical cancer is not being screened or being

screened at intervals greater than 5 years.

That's not to say that it's not painful or tragic for thousands of women,

but it's nonetheless relatively rare. There's a reason that just about

every prediction about a reduction in cervical cancer due to the HPV

vaccine is reported as a worldwide statistic. The numbers in the U.K. are

just not that high as a percentage of the population. The same is true in

the U.S., where cervical cancer is listed as a rare disease by the National

Institutes of Health.

Most women who develop invasive cervical cancer have not had regular pap

smears. So to say that because 1,000 women in the U.K. die of cervical

cancer every year, and there is thus an urgent public-health need to

vaccinate every adolescent girl -- without mentioning that many if not most

of those women did not have regular screenings -- is somewhat disingenuous.

But even if the vaccine proves to be successful at reducing overall HPV

infection, and the reduced number of HPV infections lead to a correlating

decline in cervical cancer cases -- both still huge assumptions at this

point, as the vaccine hasn't been studied nearly long enough to determine

that -- some parents still may not want to give it to their daughters.

For starters, it could cause harm. All vaccines carry the risk of injury or

death. During trials, nine individuals developed arthritis after receiving

the vaccine versus three for the placebo, out of approximately 21,000

individuals in that trial. Nine kids with arthritis after receiving the

vaccine might not seem like a big deal in the grand scheme of things. After

all, arthritis is better than cancer, right? That depends.

Given the fact that cervical cancer is relatively rare, highly preventable

and most often successfully treated early on, maybe the risk of arthritis

-- a painful and often debilitating disease -- isn't a worthwhile trade-off.

And maybe we won't know the true incidence of harmful effects until the

vaccine is given to millions, rather than thousands, of children and young

adults.

Moreover, the whole concept of a placebo was turned on its head during the

trials, preventing any valid comparison between those who were given a

placebo and those who received the vaccine.

In order to learn the truth about an unknown, honest science dictates that

we have to compare it to a known. When most people think about a vaccine

placebo, they are probably thinking about saline. But that's not what was

used during trials.

The " placebo " in this case was an aluminium-containing shot. The vaccine

itself also contains aluminium.

Aluminium hydroxide is what's known as an adjuvant — it stimulates immune

response. Studies in both animals and humans have found that aluminium

adjuvants can cause death of brain cells. Similar studies have also shown

that aluminium adjuvants in vaccines can cross the blood-brain barrier, as

well as cause injection-site inflammation leading to chronic joint and

muscle pain and fatigue.

Aluminium adjuvants have never been subjected to clinical trials for

safety. Read that again: Although the metal has been used in vaccines for

decades, it has never been rigorously studied for long-term safety.

So perhaps the 1 case of lupus and 2 cases of arthritis out of 9,701

participants who received the " placebo " were not just statistical

anomalies. Maybe it was the aluminium. Perhaps that would also explain the

1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of

arthritis and 1 case of reactive arthritis in 11,813 Gardasil recipients.

We'll never know. (Some of the trial participants did, in fact, receive

straight saline but there's no way to tell from the data released which

cases are which.)

More importantly, a reactive placebo artificially decreases the appearance

of danger of an experimental vaccine in a clinical trial because the drug

company only has to prove that adverse events weren't statistically

significant in the vaccine group versus the placebo group. So using

aluminium-containing placebos falsely inflates the adverse-event data of

the " placebo " group, making the vaccine look relatively safe by comparison.

Gardasil contains 225 mcg of aluminium. Neither Merck nor the U.S. FDA

would answer my questions as to how much aluminium was used in the placebo.

(Sanofi Pasteur MSD is marketing the vaccine in Europe and is a joint

venture of French company Sanofi Pasteur and U.S. pharmaceutical company

Merck.)

Clinical trial investigators dismissed most of the 102 serious adverse

events including 17 deaths that occurred in the clinical trials as

unrelated to the study. But given the reactivity profile of aluminium, can

we really say that for sure?

Nearly 90 percent of all Gardasil recipients and 85 percent of those who

received the " placebo " reported one or more adverse events within 15 days

of vaccination. Pain and swelling at the site of injection affected

approximately 83 percent of Gardasil recipients and 73 percent of those who

received the aluminium placebo. About 60 percent of those who received

either the vaccine or the placebo had systemic adverse events including

headache, fever, nausea, dizziness, vomiting, diarrhoea and myalgia. Those

who received the vaccine reported even more serious adverse events such as

gastroenteritis, appendicitis, pelvic inflammatory disease, asthma,

bronchospasm and arthritis.

In a never before done study, scientists recently found a link between

aluminium in vaccines and symptoms associated with Parkinson's, amyotrophic

lateral sclerosis (ALS, or Lou Gehrig's disease) and Alzheimer's.

" This is suspicious, " neuroscientist Shaw told the Georgia Straight,

Canada's largest urban weekly. " Either this [link] is known by industry and

it was never made public, or industry was never made to do these studies by

Health Canada. I'm not sure which is scarier. "

Shaw said there could be 10,000 studies showing aluminium hydroxide is safe

to be injected, but that he hasn't been able to find one study that looked

beyond the first few weeks of injection. The reason this is significant,

according to Shaw, is that neurological damage can take years to manifest.

Indeed, this is what we see time and again in vaccine studies. Either the

placebo itself contains aluminium, which doesn't much allow us to learn the

reactivity profile of the experimental vaccine, or the participants are

only monitored for safety issues for a small frame of time, or, as in the

case of Gardasil, both.

What Shaw and his colleagues found was neuron death. That's no small thing,

as it's implicated in hundreds of medical conditions. If someone has a

controlled, long-term study that shows aluminium hydroxide is safe, he

said, please " put it on the table. That's how you do science. "

Participants in the Gardasil studies were monitored for, at most, four

years and many for a considerably shorter time frame. The largest trial is

scheduled to be ended early and the people who were given a placebo now

will be given the vaccine, meaning it's no longer possible to study

long-term differences in health between those who received the vaccine and

those who received the placebo.

In terms of long-term safety, one sentence in the FDA's insert is

particularly revealing. " Gardasil has not been evaluated for the potential

to cause carcinogenicity or genotoxicity, " according to the insert. Yes,

carcinogenicity means the ability to cause cancer. It's also not known

whether the vaccine can cause chromosomal damage. We don't know because

researchers didn't look. The trials were not set up to examine that question.

The vaccine is approved for use in girls as young as nine. The rationale

for doing so is that the vaccine is only effective prior to exposure to HPV

and actually leads to increased risk of precursors to cervical cancer in

those previously infected, so it's best to catch girls as early as

possible. Yet only 100 9-year-olds received Gardasil in trials, adding to

the unknowns about administering a vaccine on still developing bodies.

Those children have only been followed for 18 months.

If this vaccine turns out to have safety issues are we even going to know?

Or will it remain on the childhood vaccinations schedule long after many

girls suffer serious side effects or worse?

Even more terrifying is the idea -- being put forth by some HPV vaccine

proponents -- of giving the vaccine to toddlers so as to weaken the

possible connection between a vaccine for a sexually transmitted disease

and " promiscuous " behaviour by youngsters.

Dr. Anne Szarewski, a consultant for Cancer Research UK who worked on the

vaccine trials, told The Telegraph that giving the shot to young children

was a good idea, provided that its efficacy could be proved to last into

adulthood.

" There is an argument to giving it to toddlers, because you get away from

any links between sexual activity and the whole ethical question that it

poses, " Szarewski said.

Even entertaining the idea of giving the vaccine to 2- and 4-year-olds is

ludicrous at this stage give that the trials have thus far lasted well

short of a decade, and we have no idea how a toddler's immune system would

cope.

We do know generally that vaccines stimulate qualitatively inferior

immunity than natural exposure, and for this reason most vaccines are

" boosted " periodically during childhood or adolescence. Naturally acquired

immunity lasts much longer, perhaps even a lifetime. The vast, vast

majority of people who contract HPV pass the virus without symptoms.

Even if we're talking about vaccinating 9- to 12-year-olds, we still have

no reason to believe at this point that the duration of immunity would last

that long or until their first sexual encounter.

Dr. Clayton Young, a board-certified obstetrician gynaecologist in Texas,

outlined his objections this way: " Vaccinating these children against HPV

with a vaccine that is of unknown duration of efficacy will only postpone

their exposure to an age which they are less likely [to] clear the

infection on their own and be subject to more severe disease.

" The study of the vaccine in children and adolescents is limited to only

measuring the development of antibodies to the HPV subtypes in the

vaccine, " Young continued. " There is absolutely no evidence that the

vaccine prevents anything when administered at this young age. Merck

expects you to extrapolate their adult data to the immune response in

children. If they were really interested in vaccine efficacy in children,

should it not be studied properly in children? "

Sanofi Pasteur and Merck have an enormous amount at stake in the universal

administration of the shots. A place on the childhood vaccination schedule

means a steady and exponentially larger revenue stream. Financial analysts

predict Gardasil could be Merck's most important pipeline contributor to

top-line growth, with peak sales of at least $2 billion -- revenue Merck

badly needs after the Vioxx scandals. That revenue figure assumes that

Gardasil will be required for school admittance.

" It's a stockholders dream, " said Barbara Loe Fisher, president of the

NVIC, a U.S. non-profit organisation that promotes the right to informed

consent on vaccine decisions. Fisher sat on the FDA's committee that

reviews vaccines in 2001, when the vaccine underwent early reviews.

Fisher went on to explain that Merck did not reveal in public documents

exactly how many 9- to 15-year-old girls were in the clinical trials and

how many of them had serious adverse events after being injected with

Gardasil or the aluminium-containing placebo. " For example, if there were

fewer than 1,000 little girls actually injected with three doses of

Gardasil, it is important to know how many had serious adverse events and

how long they were followed for chronic health problems, such as juvenile

arthritis.

" This has nothing to do with kids and whether they are going to have sex, "

Fisher added. " It has to do with whether they are going to be set up for

chronic inflammatory disease " from yet another vaccine being added to the

litany of those they already receive. " I would want more data on long-term

effects of autoimmunity on certain genotypes, " she said in an interview,

" and whether this vaccine is going to harm far more girls than it is going

to protect. "

Dr. Laing, a specialist in medical ethics at London Metropolitan

University, was equally as critical: " Diseases associated with promiscuity

will never be eradicated by universal state vaccination, " she told The

Telegraph. " The interests of the vaccine manufacturers should not take

precedence over the rights and safety of children. "

Suzanne is a freelance journalist and writer living in New Orleans.

She spent five years covering the U.S. Congress for Roll Call Newspaper in

Washington, D.C., and now focuses on subjects pertaining to health. She

also maintains a health blog at honesthuman.com.

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Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm