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The Forum > Article Comments > Gardasil: we must not ignore the risks > Comments

Gardasil: we must not ignore the risks : Comments

By Renate Klein and Melinda Tankard Reist, published 1/6/2007

Rushing Gardasil on the market in Australia for mass immunisation might be good for CSL shareholders, but what about our pre-teen girls?

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OK so let them die of a preventable disease.
Posted by ruawake, Friday, 1 June 2007 9:25:17 AM
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My wife works as a registrar in gynaecology at a public hospital and every evening over dinner I am subjected to disgusting tales of the latest cervical cancer horror story. (E.g. "She was SOOOO young and the cancer had spread EVERYWHERE!) At least it is better than talking about football.

We definitely support that boys should also be vaccinated since they are the vector for the virus. We intend to vaccinate our son when he is older.

Take a look at the authors' previous articles. Do you notice the anti-abortion/reproductive technology pattern?
Posted by michael_in_adelaide, Friday, 1 June 2007 10:29:39 AM
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Hmm.

I've some concern regarding Reist's background and I must admit I think that damages the credibility of this article.

I'm on the fence on this one. The examples I've seen aren't convincing considering tens of thousands of girls have been vaccinated. Considering the pros here, I think the cons look pretty weak.
That being said, we need to be vigilant to ensure another thalidomide never occurs - I know that's an entirely different issue and far more extreme, but all I'm saying is that we need to be careful.

Personally, I don't have ny qualms about Gardasil, I'd be happy to take an injection. Though I do have concerns about how it was approved. There's an article here on the issue, which I for one, find a little more credible.

http://www.corpwatch.org/article.php?id=14401
Posted by TurnRightThenLeft, Friday, 1 June 2007 10:47:31 AM
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Articles such as this undermine the credibility of onlineopinion.

Exactly what qualifications do the authors have? PhDs? Medical degrees? Or is it only their own crackpot, religiously-influenced, unscientific and irrational views?

So what if a few girls get side-effects. It's better than being dead.
Posted by Andrew B, Friday, 1 June 2007 11:23:47 AM
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Ok, I apologise to Dr Klein. She has a PhD. Doesn't make her views any less ridiculous though.
Posted by Andrew B, Friday, 1 June 2007 11:26:43 AM
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Very disappointing article. Perhaps three girls died from the effects of the vaccine in the United States, but many women die every year from the the hideous cancer. Now many of these may be needless deaths - one of the causes of the cancer can be vaccinated against.
I expect the reaction of everyone would be very different if it was breast cancer and / or the virus transmission was unrelated to sexual intercourse. I think that moral high ground is getting in the way of sensible public health. There will be blood on people's hands.
Posted by coothdrup, Friday, 1 June 2007 11:52:10 AM
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The first respondent to this article has missed the point - "Let them die of a preventable disease." No-one wants anyone to die of a "preventable" disease. This article is questioning the validity of this vaccine as "disease prevention" and is also questioning the safety of the vaccine considering the side effects that have been reported and the deaths. Further to this, a good point about changing behavior was made - changing behavior prevents against all sti's, not just this hpv. If young people continue to sleep around, they are at risk of more than just hpv - what about herpes? What about HIV? Maybe these two aren't as "common" as hpv, but the latter in particular is far more devastating and there is no chance of it being cleared by the immune system which is what usually happens with hpv infection.
Rather than attacking the character of the authors, how about addressing the points raised in the article?
Posted by Elka, Friday, 1 June 2007 12:05:41 PM
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This has to be one of the most irrational and profoundly ignorant pieces on OLO for a long time.

As any grandmother of average IQ would recognise, the symptoms reported by the Melbourne girls during the vaccination process are a textbook description of the somatic symptoms of anxiety. And yes, adolescents sometimes get anxious about having needles. Sometimes they even faint.

The three cardiovascular deaths reported in the US are no more than would be expected in this age group without the vaccine given the vast numbers of girls involved. While any death is tragic, there is absolutely nothing to connect those deaths with the vaccine. One girl apparently had viral pericarditis and the other two were taking the OCP – a well recognised risk factor for blood clots.

Yes Gardasil is genetically engineered, as are many of the best and safest vaccines and therapeutic products in current use. Where do Melinda and Renate think human insulin for diabetics comes from? What is their point?

The motivation behind this article is obvious. The opposition to the vaccine comes from the religious right who oppose any efforts to prevent STIs that aren’t focussed on the promotion of abstinence, an approach that could most generously be described as “public health by wishful thinking”. The authors’ half baked “feminism” does little to conceal this, and will cost women’s lives.
Posted by Snout2, Friday, 1 June 2007 12:09:48 PM
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If you want to fully grasp the culture of corruption tied to the marketing of Gardasil, click here:

How Dangerous Are Merck's Thought Police

http://www.opednews.com/articles/life_a_pam_mart_070402_how_dangerous_are_me.ht
Posted by Pam Martens, Friday, 1 June 2007 12:23:02 PM
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It should also be noted that abstinence programs are in name but not deed.
As this study suggests 'Virginity Pledgers' substitute other high-risk behaviours and are less likely to use condoms. Also they have similar rates of STD's to non-pledging teens
http://www.medicalnewstoday.com/medicalnews.php?newsid=21606
Posted by MattG, Friday, 1 June 2007 12:23:45 PM
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I made the effort to look at the report re gardasil deaths 3 hours after the injection it reads in full

"Information was received from a physicians assistant - PA, via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose of gardasil the PA reported that "the patient died of a blood clot 3 hours after getting the Gardasil vaccine" The PA clarified that the patient was not vaccinated in her office. Additional information has been requested."

So the nasty Merck, was vigilant enough to report an anecdotal report of an unspecified death.

Maybe the authors of this crud article would like to comment on the unsubstantiated rumour they cite as fact.
Posted by ruawake, Friday, 1 June 2007 12:28:33 PM
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I don't know whether it was a "sociogenic" effect or a real physiological reaction but my 16 year old daughter was very sore, sorry, dizzy and really quite ill after the first shot od Gardasil was dispensed at her southern Sydney high school two weeks ago. In fact, she was only one of three Year 11 girls left standing by the end of the school day. I also know that the response to this injection was different to other injections received by the same group at that school. Consequently, I'm less than reassured by the glib assertions about the hysteria that apparently lurks within these otherwise capable young women. I can't wait for the next installment of Gardasil in a week or so. Neither can my daughter.
Posted by DamienJ, Friday, 1 June 2007 12:44:46 PM
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Read the following and then decide if Gardasil is safe. Surely you owe it to children to do your own homework when their life is involved.

Pam Martens

Vaccine Expert Warns of Gardasil Side Effects
http://www.nvic.org/PressReleases/pr62706gardasil.htm

Leading HPV Vaccine Researcher Speaks Out Against Vaccine For Little Girls
http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txt

How Dangerous Are Merck's Thought Police (A look inside Merck)
http://www.opednews.com/articles/life_a_pam_mart_070402_how_dangerous_are_me.htm


Cancer Monthly: HPV Alone Insufficient To Cause Cancer
http://www.cancermonthly.com/iNP/view.asp?ID=169

UK Guardian Exposes Merck's Marketing Tactics in Europe (Includes Paying Journalists)
http://72.14.209.104/search?q=cache:v06zTeetjK4J:www.guardian.co.uk/medicine/story/0,,2042653,00.html+guardian+AND+gardasil+AND+raffle&hl=en&ct=clnk&cd=1&gl=us&ie=UTF-8
Posted by Pam Martens, Friday, 1 June 2007 12:57:53 PM
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Is citizen INFORMED CONSENT to medical treatment dead and buried; governments and drug companies seem to want it that way?
Year 10 Genevieve Stewart’s thoughtful letter to The Age on 29/5 states “If I had known, I would have refused the vaccination”, referring to Gardasil’s genetic modified nature and to side-effects they were not warned of. Klein and Reist’s opinion piece outlines that this vaccine is not effective against many causes of cervical cancer, in addition to the problems Stewart mentions.
One reason for public discontent with vaccines is that governments, in collusion with drug manufacturers go within a millimetre of coercing entire groups of the community to take the drugs. The exercise is so thorough that most parents and children would believe they are legally required to take it; no choice.
Yet it has been a cornerstone of medical ethics to give patients choice, free of coercian, coupled with complete information about possible dangers and limits of benefits. This is called the principal of Informed Consent
With vaccines and a number of new ‘wonder drugs’ politicians love to believe they are 100% effective and free from side-effects, and drug companies love to do their bit to foster that grand illusion.
We must hear from thinkers such as Klein & Reist, to balance the massive barrage of media releases reported in the press, that the vaccine is 100% benefit with no risk. For goodness sake, the press even regularly report the opinion of Dr Fraser, Gardasil’s inventor. You could hardly get a more emotionally invested commentator.
Posted by Ironer, Friday, 1 June 2007 3:44:25 PM
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It is a measure of the success of vaccines in promoting human health (reducing infectious disease) that the conditions of community complacency can now exist that allow widespread opposition to vaccination. If this was the 1800s where most of us would have seen siblings, parents, friends, partners etc die from infectious diseases (that are, nowadays, almost forgotten due to vaccines) the general attitude in the community to vaccination would be completely different.
Posted by michael_in_adelaide, Friday, 1 June 2007 4:08:03 PM
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Thanks to Renate and Melinda for presenting the other side of the Gardasil story. A bit of balance to this pretty scary story is what our community needs. What I can't understand is how come so many people are so willing to accept "the girls were just stressed about having the vaccine" explanation for the extreme reaction so many of them had. Questions need to be asked, like: Why has Gardisil been pushed on to our daughters and granddaughters with such haste? Whatever happened to proper procedures for trialling drugs? If this is the way Drug Companies are going to be allowed to conduct their business in the future, God help us all!
Posted by bettymc, Friday, 1 June 2007 5:12:09 PM
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re we must not ignore the risks:

in response?

"Articles such as this undermine the credibility of onlineopinion."

and

"This has to be one of the most irrational and profoundly ignorant pieces on OLO for a long time."

and

"The motivation behind this article is obvious. The opposition to the vaccine comes from the religious right who oppose any efforts to prevent STIs that aren’t focussed on the promotion of abstinence, an approach that could most generously be described as “public health by wishful thinking”. The authors’ half baked “feminism” does little to conceal this, and will cost women’s lives."

Why all the reaction? This is an argument which deserves a thorough hearing.

I will never forget the death of a friend's little sister, a long time ago, from the same vaccine that made me very ill, a long time ago. Risks and benefits must be weighed - by communities and by individuals, on the basis of hopes and fears and solid information.

Hopefully as many of us as possible have the option of an informed choice.

Thanks to the authors, and others who have posted useful links.

As for those who continue to fulminate, perhaps OLO could add to their webpages, beside their "printable version" button, an "unprintable version" button.
Posted by Sir Vivor, Friday, 1 June 2007 5:37:51 PM
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Sir Vivor,

Tankhard Reist and Klein are purporting to engage with what is essentially a scientific question: are the risks of HPV vaccination justified by the benefits?

This is a legitimate question to ask, and anybody contemplating any kind of medical intervention should always be satisfied that the question has been resolved to their satisfaction before they consent to medical treatment.

However, in composing this diatribe the authors have not referenced a single scientifically acceptable peer reviewed article about the risks of HPV vaccination (let alone about the benefits). One of the wonders of the internet is it makes it easy to search for the sources used in dodgy “scholarship” such as theirs. Here are three used for this “article”:

http://www.judicialwatch.org/6299.shtml (a US ambulance chasing group)
http://www.news.com.au/heraldsun/story/0,21985,21783101-5000106,00.html (Neil Mitchell, famous for his scientific credentials), and
http://www.909shot.com/ (The site of the so called “National Vaccine Information Centre”).

None of them is peer reviewed, or has any pretensions toward a balanced analysis of the scientific issues. The authors of this piece clearly betray their ideological bias and ignorance in the way they have composed this piece. It has no credibility whatsoever, and the fact that one of them claims a PhD is a serious worry to anyone concerned about the standards of tertiary education in this country.

The “National Vaccine Information Centre” despite its official sounding name and its claim to “promote informed consent” is little but a conspiracy theory website set up by US anti-vaccination activist Barbara Loe Fisher. This is one of the problems of the internet: anyone can set up a site and promote themselves as an authority. An academic with any claims to credibility would be aware of this, and declare the true nature of such a source.

By all means research the risks and benefits of any proposed medical intervention. Start with scientifically credible authorities such as the US CDC and follow the peer reviewed references.

http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm

It is a serious question, the authors' piece adds nothing credible to the discussion.
Posted by Snout, Friday, 1 June 2007 8:22:13 PM
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The author is renown for her stance against abortion, contraception and always follows the Catholic churchs teachings on reproduction.

If you believe in the efficacy of public immunization campaigns against diseases like polio and smallpox then you welcome the opportunity for your not yet sexually active daughter to be immunized against cervical cancer. Or you can pray that she doesn't contract the virus through premarital sex or from her husband's premarital dalliances.
Posted by billie, Friday, 1 June 2007 10:47:33 PM
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Re-message posted by ‘Michael_in Adelaide’. In the same breath, you talk about the poor death of a young woman to cancer, and next you criticise the author for being pro-life antiabortion/reproductive technology. You are a hypocrite. You intend to vaccinate your child, even though the vaccine has NOT been tested for men. Stupidity deserves to be rewarded with pain and suffering!

Re-message posted by ‘TurnRightThenLeft’. I would like to remind people that this vaccine, like all other vaccines, has NOT been tested for impairment on fertility, and nor for the possible carcinogen potential.

Re-message posted by ‘Andrew B’ you undermine Dr. Renate Klein’s qualifications. If Edward Jenner was alive today, he could have bought his qualification on ebay. He was never a doctor; he bought his doctorate from a university in Scotland. Besides, he was a bumbling idiot too. I wonder if you would like cowpox as a vaccination today for small pox. It was a gross practice then, small pox didn’t disappear – they just simply stopped vaccinating for it. These diseases are from filth, unclean water, poor sanitation and nutrition. Your doctor, 100 years ago, didn’t wash his hands after a post-mortem, and then ran off to deliver babies
Posted by Pat777, Friday, 1 June 2007 11:28:16 PM
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I believe that cervical cancer has nothing to do with sexual activity, nor the number of sexual partners. You only have to look at the cervical cancer rates and mortality to figure that out. Most of the deaths occur in women in their’ mid forties, and peak in the EARLY SEVENTIES. If it takes say twenty years or less for cervical cancer to take hold, then we are going to have to say these women in their fifties sleep around too. The truth is that there are NO deaths from cervical cancer below the age of 20 years. Figures from See page 81 http://www.aihw.gov.au/publications/can/csa03-04/csa03-04.pdf

In 1992 molecular biologists, Peter Duesberg and Jody Schwartz of the University of California, USA, found that it may be that the presence of either HPV or HSV was due to infection of proliferating cancer cells; therefore a person with cervical cancer would be more susceptible to these infections. In other words, they were indicators of infection, rather than the cause of cancer. Besides, who investigates other possible causes like the contraceptive pill? Along with personal care products.

The National Centre of Immunisation Research and Surveillance, HPV fact sheet, states: “The duration of immunity from (Gardasil) vaccination is NOT yet known”. This information was NOT included in the information pack that parents/students received from the Health department. www.ncirs.usyd.edu.au/facts/hpv_oct_2006.pdf

Re message posted by Snout2,
Possibly there may be no harm from engineered material, but who knows?? It is probably better than a live or deadened virus. God knows how many children and adults have died from SV40 tumours, which can only come from the monkey virus found in the Polio vaccine, along with the AIDS virus

The article is about questioning the safety of the vaccine. If there were a 'tin of baked' beans that made someone sick, they would all be recalled
Posted by Pat777, Friday, 1 June 2007 11:31:43 PM
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Dear me all the cranks are coming out of the wood work on this issue.

Pat you show a total lack of understanding of cancer in your first paragraph, I will let that slide. Peter Duesberg? Well what a fine example of a creditable researcher, HIV is not the cause of AIDS is his claim to fame. I cannot find any published, peer reviewed, paper where he even mentions HPV.

“The duration of immunity from (Gardasil) vaccination is NOT yet known” was said in the context of whether a second vaccination may be needed not that is was not effective.

Simian Vacuolating Virus 40? 12% of a sample of German medical students in 1952 had SV40 antibodies, note the date it is important, when was the polio vaccine introduced? How did they get antibodies to the virus if you can ONLY get it from Polio vaccines? SV40 has not been proven to cause disease in humans. In 1998, the National Cancer Institute undertook a large study, using cancer case information from the Institutes SEER database. The published findings from the study revealed that there was no increased incidence of cancer in persons who may have received vaccine containing SV40. A Swedish study confirmed these results.

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9450713
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9776244

I did get a good laugh from your website thanks, “Purpura vaccinatoria” again not in any medical literature but ” Psychogenic hemorrhagic disorders are uncommon yet must be considered in the differential diagnosis of purpura. Patients are usually young emotionally troubled females”.

Let’s have a reasoned debate, one based on evidence. Not hearsay, gossip and rumour and definitely not Pat777’s or radical feminists’ distortions of the truth. Their actions are bordering on criminal negligence
Posted by ruawake, Saturday, 2 June 2007 9:40:27 AM
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For a balanced introduction to the subject, including the political background in the US, I recommend the JAMA editorial the authors alluded to: http://jama.ama-assn.org/cgi/content/full/297/17/1921.

Contrary to the impression which might be given by the authors’ selective quotation, the editorial supports the routine vaccination of girls with the quadrivalent vaccine, as recommended by the ACIP.

The issue in the editorial is not whether the vaccine is safe and effective, or whether it should be routinely offered, the issue is whether such vaccination should be mandatory. The editorial makes a careful and balanced appraisal of the available evidence and concludes that it shouldn’t. It is also sharply critical of Merk’s behavior in lobbying the Texas government for mandatory status for its vaccine, and observes that both the Texas and Virginia governments have backed off considerably from their original ill considered decision to make the vaccine compulsory. Interestingly, it makes the point that “The use of compulsion… could have the unintended consequence of heightening parental and public apprehensions about childhood vaccinations”.

The question of compulsion and consent are complex ones, particularly in the areas of public health and when dealing with adolescents. However, they depend on a more basic issue – the scientific evidence of efficacy versus risk. Tankard-Rice and Klein have failed utterly to apply any intellectual rigor to this question, which making risk-efficacy claims central to their argument. The result is a mish mash of speculations, ramped up anxiety, and conspiracy theories.

“Informed” consent is pretty pointless if it is “informed” by hysteria and misinformation rather than actual evidence.
Posted by Snout, Saturday, 2 June 2007 12:48:17 PM
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re the CDC information on Gardasil, Minutes from the ACIP (US CDC Advisory Committee on Immunisation Practices) for June 2006 includes the following:

"The clinical trial program places strong emphasis on evaluating the safety profile of GARDASIL®. Of ~21,464 subjects, ~11,000 received detailed safety follow-up and the remainder received serious adverse experiences in medical history and pregnancy follow-up. The incidence of overall adverse events (AEs), injection-site AEs, and low-grade fevers >100°F was slightly higher in the GARDASIL® group compared to the placebo group. Systemic AEs were comparable between the two groups. Serious AEs and discontinuation due to adverse experiences were extremely rare."

I am puzzled by the statement that:
"Of ~21,464 subjects, ~11,000 received detailed safety follow-up and the remainder received serious adverse experiences in medical history and pregnancy follow-up."

Perhaps Snout can interpret that for me, or refer me to an educational site, or another source, which explains in clearer terms the meaning of this statement.

Then too, I wonder what frequency of events among a population merits the description "extremely rare". Any expert opinions, here?
Posted by Sir Vivor, Saturday, 2 June 2007 1:14:01 PM
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The New England Journal of Medicine's editorial at the link below took an in depth look at the clinical trial data on Gardasil and determined that the vaccine has only "modest" efficacy.

http://content.nejm.org/cgi/content/full/356/19/1991

What the general public does not know in order to make an informed consent is that Gardasil was never tested to prevent cancer. It may be hyped as the first vaccine to prevent cancer but there is no proof to date that it can do this. The clinical trials tested the vaccine for efficacy on precancerous lesions. Because these lesions can take 8 to 12 years or longer to develop into cancer and the clinical trials lasted less than 5 years, it is unethical to say this vaccine prevents cancer. Also, by saying this, the public is denied the ability to make an informed consent.

Pam Martens
Posted by Pam Martens, Saturday, 2 June 2007 1:22:16 PM
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Pam

Did you not read the article you posted the link to? Or did you deliberately distort what the author reported.

Another selective quote from either a fool or a liar. Please read the report again, then read your post. Then apologise.

Disgraceful.
Posted by ruawake, Saturday, 2 June 2007 2:28:13 PM
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Interesting NEJM article, Pam, but in these trials the “modest effect” of the vaccine in preventing CIN was seen in women the vast majority of whom were already sexually active. In women with no evidence of previous exposure to HPV 16 and 18 there was “efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types”. Which is why there’s a push to vaccinate girls before they become sexually active, not after.

The caveat, though lies in the “related to vaccine HPV types”. The question is, will this lead to an increase in CIN and adenocarcinoma in situ (and invasive cervical cancer) from non-16, non-18 HPV types? Plausibly, a reduction in type 16 and 18 disease might leave room for other cancer causing HPV types, which would reduce the overall effectiveness of the vaccine in preventing invasive disease.

Sir Vivor, I’m not exactly certain of the difference between “detailed safety follow-up” and “serious adverse experiences in medical history and pregnancy follow-up”. I assume the first means a structured interview of the trial participant, while the second means combing the written medical record and adverse event notifications. Don’t quote me, though.

Re what events were rare or serious, this page gives details of the trial data including a breakdown of adverse events.:

http://72.14.235.104/search?q=cache:8_Jv7zhsez0J:www.pbm.va.gov/monograph/Gardasil.pdf+21,464+subjects+trial&hl=en&ct=clnk&cd=2&gl=au

The judicialwatch site http://www.judicialwatch.org/6299.shtml also links to PDF copies of every post marketing adverse event report. I haven’t checked all 1637 of them, but a few things are clear:

Most of the vaccine related events were soreness, mild rashes, poor management of anxiety about having a shot, and vasovagal reactions common to all needles including venepunctures. US doctors need to redesign their couches so their patients stop falling off them. Not much of a catch for the plaintive lawyers’ fishing expedition.

The one type of genuinely serious event apparently caused by vaccination was Guillain Barre syndrome, a rare neurological complication of some infections and vaccinations. However these reports seem to put meningococcal vaccine given at the same time in the frame, not the HPV4 shot.
Posted by Snout, Saturday, 2 June 2007 8:28:06 PM
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Here is how the Nuremberg Code defines informed consent pertaining to medical experiments:

"The voluntary consent of the human
subject is absolutely essential. This means
that the person involved should have legal
capacity to give consent; should be so
situated as to be able to exercise free power
of choice, without the intervention of any
element of force, fraud, deceit, duress,
overreaching, or other ulterior form of
constraint or coercion; and should have
sufficient knowledge and comprehension of the
elements of the subject matter involved as to
enable him to make an understanding and
enlightened decision."

Does the public know the following or has it been intentionally submerged by an intense marketing and public relations campaign by Merck:

1. Gardasil was never tested for efficacy on 11 and 12 year old girls.
There is no proof this vaccine will work in preventing cervical cancer among this age population because the drug was never tested for efficacy on this age population.

2. There is no proof Gardasil is safe for this population because it was tested for safety among just a few hundred girls in this age population.

To most rational minds, if you have an unproven drug with unknown safety issues among a specific age population, you have an experimental drug and for a parent to give informed consent, they must be told all of the above, including that this is an experimental drug for this age population.

Pam Martens
Posted by Pam Martens, Saturday, 2 June 2007 9:30:29 PM
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WOW people are finally learning how to debate each other. Good job people.

Maybe there is hope yet.
Posted by JamesH, Sunday, 3 June 2007 6:50:34 AM
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The central issue in all this is Informed Consent, which I raised in post #14. The questions of how extensive are the side-effects, and is this vaccine effective, will be debated for some years as the evidence begins to come in.
As a society we must answer the question: is Informed Consent a primary principle to uphold, or is it window dressing to be applied in some situations only?
Pam Martens, in recent post, makes the most telling and central point with: "... if you have an unproven drug with unknown safety issues among a specific age population, you have an experimental drug and for a parent to give informed consent, they must be told all of the above, including that this is an experimental drug for this age population."
Unfortunately many of those attacking posters who are critical of the Gardasil process display a kind of blind faith, religio/scientific fervour that smacks of 'Thou shalt never question vaccines - they are all wonderful in any situation at all times'.
Vaccines, like any medical intervention should be subject to the most rigorous testing and ongoing monitoring. The authors of this essay have pointed out that Gardasil fast tracked that rigorous testing. It will be many years before we have reasonable data to know how Gardasil's cost/benefit equation stacks up. Till that time it must be treated as experimental, and Informed Consent must be honoured - including the "informed" part
Posted by Ironer, Sunday, 3 June 2007 6:08:11 PM
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My criticism of the authors of this article and the anti-vaccination warriors that joined OLO to respond to it, is that they all misrepresented the data in one way or another.

Cherry picking statements out of context is reprehensible. They stand condemned and their case is diminished because of it.
Posted by ruawake, Sunday, 3 June 2007 6:57:17 PM
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Pam, I think it’s a stretch to describe the vaccine as “experimental” notwithstanding the unanswered questions. The chain of causation from HPV infection through CIN 1,2,3 through carcinoma in situ to malignant disease is well understood. The vaccine is highly effective at stopping HPV 16 and 18 (which start the chain in 70 per cent of cases) provided women and girls haven’t already been exposed to the virus. You can’t ethically set up a trial vaccinating girls and then waiting to see how many get full blown cancer when we already understand the chain of causation. The question is not whether the vaccine will prevent cancer, but how often it will, given unknowns about the duration of protection and the possibility other cancer causing HPV types might be waiting in the wings. Merck are now claiming HPV4 might have some cross protection against other types:

http://www.pressreleases.info/EN/archive/2007/200704/20070418/20070418_146061.shtm

We’ll have to wait and see if the FDA agrees.

As for “unknown safety issues” the question is whether the safety data are good enough yet to make an informed decision about vaccinating girls. There can never be 100 per cent certainty about anything in medicine (or in life generally for that matter), but the medical consensus is that the available evidence is good enough to make that call now.

The dilemma facing parents of preadolescent and adolescent girls is do you wait for more certain data? If you do, then you risk missing the opportunity of vaccinating before your daughter is exposed to HPV 16 and 18. It’s too late, then. If you disagree with the current medical consensus, by what criteria do you decide when the data are good enough?
Posted by Snout, Sunday, 3 June 2007 10:03:05 PM
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Ironer, the question of “informed consent” is important, but complex. How much data does someone need to be “informed”, and whose responsibility is it to ensure the consenter has properly considered and understood this data? Tort law assigns the responsibility to the practitioner in principle, but is vague about how much information is enough. This keeps the plaintiff lawyers very busy.

What is “informed” in this case has been distorted by a whole range of voices with different agendas. The drug companies (following the dictates of self interest) have applied pressure to have their product inappropriately mandated on public health grounds in two US states. In claiming those mandating powers those states themselves have misunderstood public health principles. Anti vaccination activists are drumming up panic about common and minor reactions to shots, perhaps unaware that the anxiety they are ramping up is actually the cause of many of those reactions. Moral conservatives struggle with how a vaccine to prevent an STI highlights the emerging sexuality of girls. And radical feminists, fighting against the traditional patriarchy of the medical profession – sometimes with good cause - demand “full” disclosure from doctors while dismissing such information as hopelessly untrustworthy and inadequate.

The internet makes it easy to access more “information” on just about any subject than anyone can possibly digest. Whether you recognize it or not, everyone sifts according to who they have already decided is credible and authoritative. Among the competing voices do you pay most attention to the church? The state? Feminist academics? Drug corporations? Doctors? Alternative medicine proponents? Scientists?

And if you choose science, how do you navigate its complexities if this is unfamiliar territory? Is Duesberg a misunderstood genius or a stubborn crank?

The increasing tendency to question the authority of the medical profession is a good thing, but it places an increased responsibility on the consumer for his or her choices. For many, it means learning to navigate unfamiliar intellectual territory.

Choose your guides carefully.
Posted by Snout, Sunday, 3 June 2007 10:08:14 PM
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Pam - the National Vaccine Information Centre is hardly a reliable source. Take a look at what else they have opposed and the benefits they have brought to the community.

While I have some reservations about the process Merck has used to have Gardasil approved, I've no qualms about the product itself, and most of the anti-vaccine information that has been posted here is somewhat dubious.
Posted by TurnRightThenLeft, Monday, 4 June 2007 10:18:51 AM
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I am an independent writer/researcher and had never heard of the National Vaccine Information Center (NVIC) until I initiated research on Gardasil. I have thoroughly vetted the material published by the NVIC on Gardasil's safety red flags and I have found no misrepresentations.

I have personally read over 10,000 pages of Merck and/or Gardasil documents. An in-depth understanding of Merck reveals a corporation which refuses to accept the concept: "First, do no harm."

Merck currently is facing over 27,000 lawsuits for causing heart attacks, strokes and other serious health events while withholding information that its last blockbuster drug, Vioxx, was dangerous. Internal emails, published in The Wall Street Journal, confirm that Merck was aware that Vioxx carried cardiovascular risk while telling its sales force to "DODGE" the question. (That product was recalled after 160,000 deaths or serious injuries.) Merck is, according to its own SEC filing last month, under criminal investigation by the US Department of Justice.

Let's say you put an ad in the newspaper seeking a babysitter for your 11 year old daughter. A very nice sounding applicant calls you regarding the job. You ask for her references. She tells you she is facing 27,000 lawsuits for malfeasance and is under criminal investigation by the highest law enforcement agency in the U.S. Would you trust her with your child's life?

Pam Martens
Posted by Pam Martens, Monday, 4 June 2007 11:44:36 AM
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I know this is slightly off topic but I just thought I should point out this piece contained several distortions and half-truths.

Reist and Klein assert that Gardasil only protects against 2 of 13 cancer causing strains of HPV. Yet they fail to mention these two strains cause 70% of cervical cancers - a disease that affects half a million women per year. In fact Gardasil generally results in greater antibody immunity to HPV than when the infection is cleared naturally.

The authors also assert that eradication of HPV will also require vaccination of men. This is not entirely true; if all the women a heterosexual man sleeps with are vaccinated he will never get infected. Of course, we could vaccinate all men instead but the major diseases caused by HPV occur in women and as Gardasil can potentially provide protection to 20% of women who are already sexually active it’s just common sense to vaccinate women.

That said, I agree with the authors that we shouldn’t vaccinate if there is a lack of good data. However, the argument for not vaccinating should stand on its own and not rely on the unjustified smear of an effective vaccine.

References for this comment are:

Garland et al. (2007). Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. New England Journal of Medicine. Volume 356. Pages 1928-1943.

Garland et al. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases (2007). New England Journal of Medicine. Volume 356. Pages 1915-1927.

Siddiqui et al. (2006) Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) Recombinant Vaccine (Gardasil(R)). Drugs. Volume 66, Issue 9. Pages 1263-1271.
Posted by Sparky, Monday, 4 June 2007 4:14:48 PM
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Very compelling rhetoric, Pam, but nonetheless somewhat problematic.

First, Merck didn’t authorise the use of Gardasil. Its use is authorised by drug regulatory bodies in many countries.

The FDA states emphatically that Gardasil is authorised for use with 9 to 26-year-old females http://www.fda.gov/cber/products/hpvmer060806qa.htm Australia’s Therapeutic Goods Administration has approved Gardasil for 9 to 26-year-old females, with the additional note: “Immunogenicity studies have been conducted to link efficacy in females aged 16 to 26 years to the younger populations.“ http://www.tga.gov.au/docs/html/adec/adec0246.htm Interestingly, the TGA also states that Gardasil is indicated for 9 to 15-year-old males.

Nice that you’ve read thousands of pages about Merck’s business practices, but you’ve failed to reveal how this relates to the approval of Gardasil. Your objections about testing with a particular age group appear to have been dealt with, at least as far as the TGA is concerned.

Working on Wall Street, may have given you the tools to take on the business practices of Smith Barney http://multinationalmonitor.org/mm2002/02april/april02interviewmartens.html and now Merck, but I need to be convinced how that prepared you to judge drug trial sampling, over the heads of the FDA and the TGA, among others. I think you need to separate your campaign against Merck http://snipurl.com/1n63r from the debate about the use of Gardasil.

Finally, the babysitter analogy is powerful, but it doesn’t work. If your child’s life depended on using this particular babysitter, then your attitude to the risks involved would be very different. If a powerful authority told you that despite the previous record it was safe to use that babysitter, you would probably accept the risk, given the catastrophic alternative.

Parents have access to many potential babysitters, but only one approved drug for protecting their children twenty, thirty, forty years hence from avoidable disease. The informed choice, with today’s best available information, is to get the vaccination.
Posted by jpw2040, Monday, 4 June 2007 6:43:28 PM
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Dear jpw2040 (previous post)

You state: "The informed choice ... is to get the vaccination."
But that is a distortion, a failure to understand the concept of "informed choice" or "Informed consent".
Informed choice is not about you, or another authority deciding for others what choice to make. It is about individuals, about patients and their families, weighing up the information and making choices that relate to their personal situation, values, medical concerns etc etc.
How can you claim the omniscience to know what "informed choice" is for all readers, all women, all Australians.
I am sure you didn't mean what you wrote - you couldn't have. I am sure you meant to say that YOUR choice for yourself or child would be to try the vaccine.
Posted by Ironer, Monday, 4 June 2007 8:18:57 PM
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Pam, pharmaceutical companies such as Merck love to present themselves as philanthropic organizations of impeccable altruistic credentials. Many of us, however, recall Adam Smith’s words in “The Wealth of Nations (1776)”:

“It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their self-love, and never talk to them of our own necessities but of their advantages”

Jpw 2040 is right that it is up to authorities other than the brewers themselves to evaluate their claims. Whether Merck lied about what they knew about Vioxx is yet to be decided by the courts. I’ll be watching closely when alternative brewer Glaxo brings out their HPV product soon.

Also, I note that Gardasil has been approved for 9-15 year old boys in Australia, but not funded. Now the main benefit is probably the reduction of HPV related cancers in the female partners of those males, although reduction in penile cancers (very rare) and anal cancers (mostly in gay men) may be significant. But try selling that to parents in the US Bible Belt. I reckon that would defeat even Merck’s finest marketers.

Lastly, it’s fine for Tankard-Rice and Klein to quote the views of Barbara Loe Fisher and her so-called “United States National Vaccine Information Centre”. However, if they do so while implying this is an authoritative source and ignore any more balanced or opposing views they betray their own biases.
Posted by Snout, Monday, 4 June 2007 10:26:07 PM
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To fully appreciate the depth of the fake hype around Gardasil, try this: put the following phrase into the Google search engine:

hpv AND “70 percent”

It brings up 110,000 hits all referring to the “fact” that Gardasil targets HPV 16 and 18 which cause 70 percent of cervical cancer cases.

Not one link, however, will tell you where that “fact” came from. Strip away the hype and the legions of public relations firms working for Merck and you have: (1) Merck's own clinical trial findings that conclude that Gardasil has only a 17% effective rate in decreasing high grade cervival dysplasias, the precursors to cervical cancer, among a general female population. (2) The same published finding in the New England Journal of Medicine, a peer reviewed medical journal.

Prior to this Gardasil marketing blitz, the U.S. Centers for Disease Control and Prevention (CDC) and major medical journal studies explained that HPV, alone, could not be the sole factor in cervical cancer. Research showed that cigarette smoking was, at the very least, a co-factor with tobacco substances found in the cervical mucous of women who had pre-cancerous lesions.

In a July 9, 2006 Florida Supreme Court decision (revised on December 21, 2006) the court overturned a $145 Billion punitive damage award against Big Tobacco but affirmed findings that smoking of cigarettes causes a host of cancers, specifically stating that it caused cervical cancer. (Engel et al v. Liggett Group et al)

I would say that ruling could be an issue for Big Tobacco with cervical cancer causing close to 4000 deaths in the US each year and being a leading cause of cancer deaths in other parts of the world.

In looking at the “educational” legislation passed by numerous U.S. states, I find it interesting that HPV is inserted in the legislation as the sole cause of cervical cancer. Equally interesting is that among a broad group of Big Pharma donors to Women in Government, Altria (parent of Philip Morris and defandant in Engel et al v. Liggett Group et al) pops up.

Pam Martens
Posted by Pam Martens, Tuesday, 5 June 2007 1:34:19 AM
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However if you search for hpv and cancer on Google Scholar, you get a range of scientific literature that quotes where that source is. In fact you can find the paper that is most likely to be referenced:

http://jnci.oxfordjournals.org/cgi/content/abstract/87/11/796?ijkey=0d708d92354b467f4a38d726171edee53b0e09eb&keytype2=tf_ipsecsha

It even breaks down the prevalence of each HPV by region, how about that!

I'm sure you will find it very interesting reading and yes, the link between cervical cancer and HPV is strong and independent of other factors.

Read the peer-reviewed science, stop reading nutbag websites and then make your decison. Use Google Scholar,or Pubmed, they have properly reviewed literature and should always be the first resource for making informed decisions.
Posted by Bugsy, Tuesday, 5 June 2007 2:03:03 AM
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I didn't have to read the entire article. As soon as I saw that the authors were citing the National Vaccine Information Center as some sort of authority I knew that I would be wasting my time. You don't cite Holocaust deniers when discussing history, you don't cite AIDS deniers when seriously discussing public health, and you don't cite anti-vaccination liars when discussing vaccines. NVIC exists to oppose all vaccines for all people of all ages against all diseases. All Barbara Loe Fisher needs to know is that it is a vaccine, and that is enough for her to oppose it.

Once upon a time the anti-vaccination liars only hated children. Now they hate women as well.

Peter Bowditch
www.ratbags.com
Posted by Peter B, Wednesday, 8 August 2007 3:31:48 PM
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Melinda Tankard Reist is well known for her pro life, pro mandatory pregnancy views. The issue here is not that some girls may have a reaction to the vaccine, it is about religious views on sexuality and women's role.

Bridget Maher of the Family Research Council told the British magazine "New Scientist" that: "Giving the HPV to young women could be potentially harmful, because they may see it as a license to engage in premarital sex." http://www.newscientist.com/channel/sex/mg18624954.500-will-cancer-vaccine-get-to-all-women.html

As repulsive as her views are, at least Bridget Maher was honest about her motives and did not insult women by pretending concern for their health. Women's health and the pro life ideology are mutually exlusive.
Posted by Maryan, Sunday, 19 August 2007 9:49:53 AM
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