Gardasil

The resources section has a tutorial on Gardasil which can "teach" you a lot of basic information.

The September 2008 issue of Health Options has an article on Gardasil.

Here is the document sent to them with references.  One reference has the wrong PMID number, but the reference is correct.

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After the article in Health Options in September, Natalie Desmond the National Advisor, Immunisation Advisory Centre, at the University of Auckland replied in October.

Her letter read:

Dear Healthy Options,

I would like to take the opportunity to update the research on cervical cancer and the Human Papilloma Virus (HPV) vaccine presented in your September 08 issue (p54).  The studies mentioned appear to stop in the year 2000.  As your article notes: mother to child transmission of HPV virus can occur, however, this is very rare (Ref Winer RL 2004, Smith EM, 2004).  Importantly infant infection is not likely to lead to HPV DNA detected later in life (Ref Schlecht NF, 2001).  Most genital infections of HPV occur following sexual contact and sometimes by non-penetrative sexual contact (Ref Winer RL 2005).  As Dr Eileen Dunne of the Centres for Disease Control and Prevention, Atlanta said, “The available epidemiological data strongly support the primary role of sexual activity in transmission of HPV; as a highly prevalent infection it is easy to transmit between partners, even with one sex act.”  (Ref Manhart 2006, Dunne 2007.)  Most women (around 80 per cent) become infected at some stage of their lives and most will clear HPV infection.  However around 2 per cent develop persistent infection and cervical cell changes that can lead to cancer if not detected and treated via the cervical screening programme.  Your article raises many questions that have been addressed by more recent studies which your readers may be interested in and they are available free online via Pubmed.  Nobody has all the answers and scientific research must always continue.

Therefore as parents we must base our judgements on the best available evidence at the time.  Studies involving some 20,000 women have clearly demonstrated that HPV vaccination is effective at preventing the precursors to 70 per cent of cervical cancer in most women vaccinated prior to infection (Ref Koutsky 2002, Villa 2005, 2006, Garland 2007).  This evidence is one of the key reasons why New Zealand has joined the countries fortunate enough to be able to offer HPV vaccine free to improve women’s healthy.

Natalie Desmond, National Advisor, Immunisation Advisory Centre,

 University of Auckland, Auckland.

Here isa scanned copy.

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 It is a truism that it’s a lot harder to rebut mini soundbites. 

In reply to “she’s wrong”, justification can take much more space. 

Here is my letter to Healthy Options, which was restricted to a 300 word count.  After this letter, is the version I would have like Healthy Options to print, but it doesn't fit in the word count:

To be published:

Dear Healthy Options:

Diversionary tactics away from the topic of my article in September, will not alter the evidence.  While Natalie Desmond believes that Mother to Baby infection of HPV is irrelevant, recent research shows that she is on her own, in that belief.  Transplacental transmission of HPV from mothers to babies was reported in a study published on 25th September 2008, which can be seen here:  http://www.virologyj.com/content/5/1/106

The rates of infant infection were significant, and the authors said, “The possible consequence of fetal exposure to HPV should be observed.”

Importantly for women, FDA’s Dr Nancy Miller who approved the licensing of Gardasil, issued a warning saying that Gardasil injected into women previously infected, *increases* those women’s risk of developing precursors to cervical cancer.

The inventor of Gardasil pointed out (Frazer I *2006* PMID 16920633 page181), that individuals can have full effective cellular immunity to HPV viruses, yet have no detectable antibodies, stating, “The basis for protection is unclear.” Absence of virus, or antibody, according to the current tests, does not mean that a person hasn’t been infected, or that they don’t have immunity.

This being so, I'm not sure we should be so quick to state that this country is "lucky enough" to have acquired this vaccine, before we see can confirm that the vaccine actually does what is, right now, solely a prediction. I do concur however, that nobody has all the answers and that scientific research must continue.

Contrary to Natalie Desmond’s assertion that members of the public can access the articles freely on Pubmed, many are only available on a  “pay per view” basis, and would likely cost a few hundred dollars.

A more comprehensive response to Natalie Desmond’s letter is available (on this page).

Here is the more complete version: 

Had National Advisor of the Immunisation Advisory Centre, Natalie Desmond, asked Healthy Options or myself for the references, she would see they stopped at 2006, not 2000.  Natalie says that nobody has the answers and that research must continue.  Very true.

Transplacental transmission of HPV from mothers to babies was reported in a study published on 25th September 2008   http://www.virologyj.com/content/5/1/106  in which 12 of 49 placentas tested positive for HPV DNA, eleven newborns tested HPV DNA positive from cord blood, body, mouth or nose swabs.  The authors reported placental infection in 23.3%; transplacental transmission in 12.2%.  The authors said,

"The possible consequence of fetal exposure to HPV should be observed.”

I do not consider this a rare event. Natalie Desmond said, “Importantly, infant infection is not likely to lead to HPV DNA detected later in life.” Transient infections in young women, which result in immunity, are only detectable for 168 days (Brown DR, 2005. PMID 15609227).  93% of sexually active women, have a different viral type detected four menstrual cycles later (Hinchliffe SA 1995. PMID: 7547245).   Therefore you would not expect to detect virus contracted as a baby, in an adult, unless it was a persistent infection. 

If Gardasil is to be given to women not yet infected, then ongoing transmission in children must be treated seriously as detailed in:

1)     the Finnish HPV Family study, (Rintala 2005. PMID 16288396) “…Oral HPV infection was acquired by 42% of children, cleared by 11%, and persisted in 10% of the infants, whereas 37% were never infected. The corresponding figures for genital HPV infection were 36%, 14%, 1.5%, and 47%.  Persistent carriage of high-risk HPV types was detected in oral and genital mucosa specimens obtained from 10% and 1.5% of the infants during their first 26 months of life. …This information is necessary to help HPV vaccine studies focus on the correct age groups and populations for vaccination, as well as … to decrease the number of lawsuits related to false allegations of sexual abuse.”

The Finnish study mentioned a 1995 study, (Cason J PMID 8551271) “Perinatal infection and persistence of human papillomavirus types 16 and 18 in infants”, which showed that persistent carriage of HPV type 16 in the infants studied was 83% and HPV 18, 20% after 6 months follow up. 2003 studies showing evidence of HPV types in children: PMID 13679205, 14556274, 14556274.

2)     Mammas 2006. PMID 17133162.  HPV-16, -18, -33 and -11. RESULTS: HPV DNA was detected in 9 (8.5%) of the 106 collected specimens. The frequencies of HPV typing were 6 of 9 (66.7%) for HPV-16, 2 of 9 (22.2%) for HPV-11, zero of 9 (0%) for HPV-33 and HPV-18, one HPV-positive sample untyped. No multiple HPV infection was detected. HPV was detected in 6 (9.4%) children with tonsillar hyperplasia and in 3 (7.1%) with adenoid hyperplasia.

All these studies indicate significant rates if infant HPV infection. 

The three studies Natalie quoted as proving that perinatal transmission is a non issue, looked at the viral strains of HPviruses  which existed in both mother and their babies.  Because the mothers tested at birth had different viruses to their babies, the authors said that the babies didn’t get the virus during birth.  They suggested that the babies might have acquired the virus during pregnancy, instruments used in deliver, from other people, or even that the virus found was a testing “contaminant” with nothing to do with either mother or baby! 

There is a newer vexed question as to whether the tests used up till now are sensitive enough to pick up all the HPV types in an individual.  Page 26 in a 2007 FDA docket, http://www.fda.gov/ohrms/DOCKETS/DOCKETS/07p0210/07p-0210-ccp0001-01-vol1.pdf shows that in comparison to a newer test not yet approved, the old tests all fail to detect large numbers of HPV genotypes.

Study results are only as accurate as the tests used to define the “problem”.  This question mark over current testing kits therefore applies to the Merck vaccine trials used as a basis for Gardasil approval, as well as any subsequent trials using unreliable testing methods.  Therefore, study conclusions inferring “no virus” may not be proof that virus isn’t there.

The medical studies above indicate that:

·         HPV types in the Gardasil vaccine(as well as many other types), can be transmitted from mother to baby (by whatever means)

·         freely circulate within families, as well as child to child in a social context.

·         Infections in children will mostly be transient, as with adults, with evidence of infection  disappearing in the healthy individual. 

The inventor of Gardasil pointed out (Frazer I 2006 PMID 16920633 page181)  that individuals can have full effective cellular immunity to HPV viruses, yet have no detectable antibodies, stating, “The basis for protection is unclear.”   Absence of virus, or antibody, according to current tests, does not mean that a person hasn’t been infected, or that they don’t have immunity.

All studies discussing HPV infection in babies and children have repeatedly given warnings about the implications of these facts when implementing any vaccination programme.  Merck and others continue to ignore all the literature, and all warnings.

Natalie asserts that the references she quotes demonstrate that “HPV vaccination is effective at preventing the precursors to 70 per cent of cervical cancer in most women vaccinated prior to infection.”

First, prove that the women weren’t infected as babies or children. You can’t, if you don’t pre-test, or if the test is inadequate to accurately pick up HP viruses a woman has previously been infected with.

Health Department publicity states that Gardasil will eliminate 70 percent of all cervical cancers. 

I note Natalie did NOT use the word cancer, but very carefully said that Gardasil will prevent precursors.  What she did not say was that the day FDA’s Dr Nancy Miller approved Gardasil, she issued a warning saying that Gardasil injected into women previously infected, increases those women’s risk of developing precursors to cervical cancer.

Gardasil only is only effective against CIN I smears.  WHEN it comes to the POINT of the vaccines, CIN II and III smears, Gardasil had only a 17% efficacy. ( Sawaya GF 2007. PMID 17494933, and Table 285, page 368, http://www.fda.gov/cber/review/hpvmer060806r.pdf  Merck's Gardasil licence application.).  Whether or not Gardasil lives up to the company’s belief that it will prevent ACTUAL cancer in a person uninfected at the time of injection, is a belief not yet proven.

As of today(20 November 2008), the queues of New Zealand women lining up for Gardasil have been sparse.

Given that Gardasil, like MeNZB, is being promoted as very safe, with no side effects, how many New Zealand parents will end up fruitlessly complaining about “serious side effects” in their daughters after the school Gardasil programme is rolled out?  Will New Zealand sail on the same autopilot setting as other countries which continue to refute everything, apart from “stinging”, as being coincidental?

Natalie Desmond stated that the articles she cited and more are free to the public, on Pubmed.  This is incorrect.

Public taxes pay for Auckland University access to Philson Medical Library, which Natalie is priviledged to access at no cost to herself. In order to access and read some of the articles cited the public are required to “pay per view” which would cost a few hundred dollars. This point is further aggravated by the fact that of three of the authors referred to in Natalie’s references Pubmed throws up:

three possible  HPV articles by Schlecht 2001,
six possible articles for Dunne 2007, and
seven possible  articles for Garland, 2007 with abstracts giving no clue as to which one to read.   

If IMAC used PMID numbers, readers would know which specific study is being referred to.

On a personal note:

Natalie states that about 80% of women will become HPV infected at some stage in life; most will clear the many types (120+)however around 2% will develop persistent carriage potentially leading to cervical cell changes.

We understand this problem.

A relative of ours was one of those supposed 2% of women.  After returning a third CIN III smear, she consulted a “heretic” doctor who understood the issues of micronutrients (PMID 17553901) folic acid  (PMID: 17276035) as well as other means of reversing damage already done, which are ignored by most pharmaceutically based doctors. 

Within a year, her smears returned to normal.  With a permanent lifestyle change, for the last decade, her smears continue to come back normal.  Yet nearly a decade after her smears returned to normal, her gynecologist continues to want to remove her normal cervix (and probably more) “just in case”. 

Because the medical profession constantly presents cervical cancer as a fearful  random event which cannot be prevented and could affect “anyone”; which can only be controlled or cured with lots of stress and agony, parents are being falsely lead to believe that Gardasil is the only prevention or answer to the problem, when real protection might be right there, on the meal table, and through lifestyle changes which might change not only susceptibility to cancer, but a whole raft of other health problems as well..

Natalie asserts that the references she quotes demonstrate that HPV vaccination is effective at preventing the precursors to 70 per cent of cervical cancer in most women vaccinated prior to infection.

First, prove that the women to be vaccinated haven’t been infected in the past. And prove that vaccinating women already exposed will not, as Dr Millar said, increase their risk of cancer precursors.