Study should dispel HPV vaccine myths

A large US study has added further support to the safety of the Australian-developed human papillomavirus vaccine (HPV4). The study, published in Archives of Pediatrics & Adolescent Medicine, included 189,629 girls and young women, and found there was no evidence of serious safety concerns secondary…

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A major US study has added support to the safety of the HPV vaccine. AAP

A large US study has added further support to the safety of the Australian-developed human papillomavirus vaccine (HPV4).

The study, published in Archives of Pediatrics & Adolescent Medicine, included 189,629 girls and young women, and found there was no evidence of serious safety concerns secondary to HPV4.

The study found the vaccine appeared to be associated with fainting on the day of vaccination, an issue more generally associated with immunisation and needles, as well as skin infections in the two weeks after vaccination. However the researchers commented that some of the cases may have been local injection site reactions.

“These findings support the general safety of routine vaccination with HPV4 to prevent cancer,” said study leader Nicola Klein of the Kaiser Permanente Vaccine Study Centre.

Persistent genital HPV infection can cause cervical cancer in women. The vaccine to prevent HPV, developed by Australian immunologist Ian Frazer, was approved by the US Food and Drug Administration in 2006, and Australia introduced its own national HPV vaccination program for women aged 12-26 years in 2007.

Professor Frazer, director of the Diamantina Institute for Immunology and Cancer Research at University of Queensland, said the study was designed specifically to avoid bias, and confirmed previous reports that the HPV vaccine is as safe as other vaccines.

The cohort study compared the odds of emergency department visits and hospitalisations soon after vaccination, with odds during a comparison interval more remote from the vaccination.

“The study design minimised the possibility of two problems: firstly, attributing rare and serious health events inappropriately to vaccination, and secondly, missing an increase in common and minor health events due to vaccination.”

Social researcher Spring Cooper Robbins said despite earlier studies showing it was safe, rumours about risks and the HPV vaccine persisted among adolescents.

The politicisation of the vaccine and its role in preventing a sexually transmitted disease has also flamed misleading discussions about the vaccine.

Dr Robbins is working on a program to deliver factual information about the vaccine to adolescents.

“In Australia in the school-based program there isn’t information provided directly to adolescents, it’s only provided to parents.

“Adolescents get quite anxious because they don’t always know what they’re getting and why,” Dr Robbins said.

She added that while there was an expectation that parents would discuss the information with their children, this did not always happen.

“Some parents are uncomfortable because of the association with sex – they don’t want to bring it up.”

Dr Robbins said because the vaccine was sometimes called the “cervical cancer vaccine” there was sometimes confusion about the nature of the vaccine.

“Some of them think there’s cancer in the vaccine to help their body fend it off, but that’s not how it works.”

She added that it wasn’t minor issues like fainting and skin infections that adolescents were worried about, but instead the pain of the injection or major complications.

“They’ve heard HPV hurts more than other vaccinations. It does feel different.”

But she said even young adolescents studied were able to articulate: “I don’t mind having my arm hurt for a few days now if it means I won’t get cancer in the future”.

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38 Comments sorted by

Comments on this article are now closed.

  1. Laurie Willberg

    Journalist

    "This study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4"
    We'll just go on worrying about the "old" safety concerns, like permanent paralysis, cardiac events and death.
    When parents/patients are apprised of the fact that over 70% of infections can be prevented with condoms, over 90% of HPV infections clear up on their own and don't persist, the vaccine only claims to protect against 4 strains of HPV out of 100, and doesn't offer lifelong protection (not to mention probably interfering with the bodies' own ability to fight off infections) HPV vaccines are nothing more than a profit centre for the manufacturer.

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    1. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Laurie Willberg

      Laurie, re your comment "HPV vaccines are nothing more than a profit centre for the manufacturer". FierceVaccines reports on the 20 Top-selling Vaccines - H1 2012 (first half financial year). Gardasil (Merck) comes in at No. 3 with sales of $608 million and Cervarix (Glaxo Smith Kline) ranks at No. 8 with sales of $285 million.
      FierceVaccines also reports: "Data on the biggest-selling vaccines helps us understand what's driving growth in the vaccines industry, and which companies are behind the wheel. Thanks in part to the adult influenza market and vaccines such as Gardasil and Prevnar, the global vaccines market has enjoyed a decidedly solid boost in revenue. Ten years ago, the vaccine market sat at $5.7 billion dollars, according to Kalorama Information. Now, that market has soared to $27 billion."
      Reference: 20 Top-Selling Vaccines - H1 2012. 25 September 2012. Alison Bryant, Fierce Vaccines: http://www.fiercevaccines.com/special-report/20-top-selling-vaccines/2012-09-25

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    2. Sue Ieraci

      Public hospital clinician

      In reply to Laurie Willberg

      The above two posters seem not to understand the dynamics of public health campaigns.

      The reasons for FluVax and HPV vax being big earners in recent years are easily explicable.

      For Influenza vaccination, the campaign for widespread vaccination occurred in the context of a worldwide pandemic, where the achievement of a high immunity rate was required to limit the extent of the pandemic.

      In terms of HPV, this is a "catch-up" phenomenon - any new vaccine will have a boost in sales while everyone eligible is covered.

      There is no need for conspiracy theories. OF course the developers and manufacturers have profited - just like any developer and manufacturer of an effective product does. Let's face it, even multinational homeopathic manufacturers like Boiron can make huge profits without even having to show efficacy for their products - or even having to include therapeutic ingredients.

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    3. Laurie Willberg

      Journalist

      In reply to Sue Ieraci

      Oh we understand the "dynamics of public health campaigns" all right and have found them to be mostly ineffective and frequently having nasty consequences.
      Speaking of homeopathic products, Boiron's Oscillococcinum flu remedy has been shown in clinical trials to reduce flu symptoms by at least a week. The pharma product Tamiflu has been shown to possibly reduce symptoms by 24 hrs. The Oscillo. remedy is also WAY CHEAPER.
      You should know by now that Homeopathic treatment is geared towards the individual patient. While there are some "condition specific" remedies the treatment needs to be individualized. Drugs are tested to be condition specific. Homeopathy has never been practised that way. Still, the Banerji Protocol for the treatment of brain tumors is condition specific and has been approved by the National Cancer Institute in the U.S. for example.
      You should really limit yourself to subjects you know about. Homeopathy isn't one of them.

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    4. Sue Ieraci

      Public hospital clinician

      In reply to Laurie Willberg

      "Boiron's Oscillococcinum flu remedy " - one of the great scams of Big Tincture.

      At the turn of last century, a French guy called Roy examined the blood of soldiers who had influenza and thought he saw an oscillating bacterium, which he called Oscillococcus. UNfortunately, he was wrong - flu is caused by INfluenza Virus. He was wrong about other things too - he thought that this organism also caused various other conditions including cancer, and he thought he had identified the same organism in a duckling.

      Somehow, this doesn't stop gullible people in the 21st century buying a "remedy" that allegedly used to contain extract of duck liver and heart - but no longer does. Cheaper than an antiviral? - of course it is - there's nothing in it! And Boiron continues to get away with it! Pure scam.

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  2. Elizabeth Hart

    Independent Vaccine Investigator

    Ian Frazer's article "Catch cancer? No thanks, I'd rather have a shot", published on The Conversation on 10 July 2012, (plus extensive comments on the article), is also relevant: http://theconversation.edu.au/catch-cancer-no-thanks-id-rather-have-a-shot-7568 Why isn't it listed in the Related Articles section?

    In that article Ian Frazer stated: "Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them…

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    1. Craig Morton

      Biomedical Research Scientist

      In reply to Elizabeth Hart

      Elizabeth there is plenty of literature on the cost/benefit ratio for HPV vaccination - more than 300 articles in PubMed if you search for "HPV vaccine cost effectiveness" from many different countries by many different groups.

      http://www.ncbi.nlm.nih.gov/pubmed?term=HPV%20vaccine%20cost%20effectiveness

      a key recent reference being:

      http://www.ncbi.nlm.nih.gov/pubmed/22413761

      The key findings appear to be that vaccination of young women is cost effective, in terms of cost per QALY saved. Vaccination of boys is less well supported, though further analysis of specific populations (particularly MSM) is indicated to see if there is an advantage to treating them separately.

      In short, the supporting data for the cost-effectiveness of universal vaccination of young women are strong.

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    2. Sue Ieraci

      Public hospital clinician

      In reply to Elizabeth Hart

      Elizabeth Hart - you have clearly done some critical thinking in this area.

      Could you please tell us what is the NNT for HPV vaccine to prevent a case of cervical cancer requiring treatment, and what your estimation of the cost-benefit ratio is?

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    3. Sue Ieraci

      Public hospital clinician

      In reply to Elizabeth Hart

      Elizabeth Hart - you have clearly done some critical thinking in this area.

      Could you please tell us what is the NNT for HPV vaccine to prevent a case of cervical cancer requiring treatment, and what your estimation of the cost-benefit ratio is?

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    4. Sue Ieraci

      Public hospital clinician

      In reply to Elizabeth Hart

      Elizabeth Hart - you have clearly done some critical thinking in this area.

      Could you please tell us what is the NNT for HPV vaccine to prevent a case of cervical cancer requiring treatment, and what your estimation of the cost-benefit ratio is?

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    5. Sue Ieraci

      Public hospital clinician

      In reply to Elizabeth Hart

      Elizabeth Hart - you have clearly done some critical thinking in this area.

      Could you please tell us what is the NNT for HPV vaccine to prevent a case of cervical cancer requiring treatment, and what your estimation of the cost-benefit ratio is?

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    6. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Sue Ieraci

      Sue, thank you for all your messages. You've demonstrated that you’re up with the jargon - is there any information you would like to share?

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    7. Sue Ieraci

      Public hospital clinician

      In reply to Sue Ieraci

      Apologies for the repeated messages - computer glich.

      Yes, Elizabeth Hart, I am familiar with medical research jargon because I update my skills regularly at workshops and seminars. That's why I am curious about how you have made different conclusions to the researchers. Would you care to share your reasoning, and what data it is based on?

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    8. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Craig Morton

      Craig M, thanks for the link to your PubMed search and the 317 abstracts. Thanks also for the link to the cost-effectiveness of HPV vaccines review abstract. As I acknowledged on the “Catch Cancer…” discussion thread http://theconversation.edu.au/catch-cancer-no-thanks-id-rather-have-a-shot-7568 I don’t claim to be an expert in anything…least of all economics and statistics etc. I have to admit my eyes start to glaze over when I see reference to terms such as ‘model structures’, ‘input parameters…

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    9. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Sue Ieraci

      Sue, I’ve reached my conclusion that HPV vaccination is highly questionable based on this statement by Ian Frazer, co-inventor of the technology enabling the HPV vaccines, i.e. “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection. Even if the infection persists, only a few individuals accumulate enough genetic mistakes…

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    10. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Elizabeth Hart

      Mexico has now launched a “massive program to vaccinate fifth-grade girls against human papillomavirus, making it one of the few nations in the world with a universal campaign against the sexually transmitted virus. One million schoolgirls ages 11 or 12 will receive the HPV vaccination this week, Mexican President Felipe Calderon said. Another 200,000 girls who aren’t in school also will be given the vaccine…”(1)
      The international HPV vaccine juggernaut is gathering momentum. So many people in the medical and scientific establishment, and government, have hitched their wagon to this ‘Australian innovation’, a very questionable medical intervention which is being pressed upon 12/13 year old children.
      Where are the whistleblowers?
      Ref. 1: “Mexico orders HPV vaccinations for all 5th-grade girls, saying it will end threat of cervical cancer”. The Kansas City Star, 3 October 2012: http://www.kansascity.com/2012/10/03/3846457/mexico-orders-hpv-vaccinations.html

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    11. Sue Ieraci

      Public hospital clinician

      In reply to Elizabeth Hart

      OKAY - so on the basis of a quote from an article on a comment site, and without even understanding what the NNT means, let alone what it is, you disagree with the decision-makers behind the PBS and the national vaccination program. ON what basis would anyone prefer your view?

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  3. Craig Sinclair

    Director, Cancer Prevention Centre, Cancer Council Victoria

    The results from this study will hopefully help to ease concerns from parents and adolescents in Australia and encourage eligible students to have the HPV vaccine under the school-based program.

    Cancer Council Victoria has made a commitment to provide comprehensive and evidence-based information on the HPV vaccine to not only parents but to all relevant parties including schools, health professionals, local councils and teens.

    Our national website – www.hpvvaccine.org.au – was developed largely…

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    1. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Craig Sinclair

      Craig, I've had a look at the Cancer Council Victoria’s Cervical Cancer Vaccine website: www.hpvvaccine.org.au
      Looks like you’re pulling out all the stops on that marketing campaign…
      Your website notes that "HPV is a very common sexually transmitted infection which usually causes no symptoms and goes away by itself, but can sometimes cause serious illnesses". As your website advises that "in most cases the immune system clears HPV from the body naturally over time and has no long-lasting effects", I am aghast that the HPV vaccine is being aggressively pushed onto mass populations of healthy children.
      A couple of questions Craig:
      1. Is there a transcript available of the video “directly targeting adolescents”, i.e. “Everything a girl should know about the HPV vaccine”?
      2. Perhaps I couldn't see it for looking, but I couldn't find a copy of the HPV vaccine consent form on your website. I’d be interested to have a look at the consent form - is there a link available?

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    2. Craig Sinclair

      Director, Cancer Prevention Centre, Cancer Council Victoria

      In reply to Elizabeth Hart

      Hi Elizabeth, unfortunately not all cases of HPV infection will clear on their own, and it's these usually high-risk types that can cause cell changes which if left untreated, could develop into cervical cancer. We’re already seeing extremely positive preliminary results from HPV vaccination with a 50% decline in pre-cancerous cervical lesions in young women since the introduction of the vaccine, as well as a 90% drop in genital warts in young women and men. We will continue to promote the program because we believe it provides significant benefits to girls and the wider community. You can view the video ‘Everything a girl should know about the vaccine’ on the homepage of our website. Consent cards are available for each state/territory and in Victoria you can find them on the Victorian Department of Health website at the following link http://www.health.vic.gov.au/immunisation/resources/human-papillomavirus.htm

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    3. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Craig Sinclair

      Craig S, re your comment: “We’re already seeing extremely positive preliminary results from HPV vaccination with a 50% decline in pre-cancerous cervical lesions in young women since the introduction of the vaccine, as well as a 90% drop in genital warts in young women and men.”
      Can you please provide the reference to support that statement? Thanks.

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    4. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Craig Sinclair

      Craig S, I've viewed the Cancer Council video 'Everything a girl should know about the HPV vaccine' a few times now. Did this video go through an ethics approval process? I'd still be interested in a transcript if it's available.
      And also a response to my previous request for a reference, above.

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  4. Edward John Fearn

    Edward John Fearn is a Friend of The Conversation.

    Hypnotherapist and Naturopath

    Cervical cancer used to be the leading cause of cancer death for women in the United States; (1) rates have reduced somewhat thanks to pap smears and targeted public education programs. In Australia we have also seen a steady reduction of cases through similar interventions.(2) However 80% of cervical cancers occur in developing countries,(3) and account for most of the 253,500 deaths per year. In many of these countries access to two yearly Pap smear tests for all women is simply not feasible. The HPV vaccine has the potential to save thousands of lives in these developing countries where most simply do not have the luxury of any other choice.

    (1) http://www.cdc.gov/cancer/cervical/statistics/

    (2) http://www.papscreen.org.au/browse.asp?ContainerID=c15

    (3) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876324/

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    1. Laurie Willberg

      Journalist

      In reply to Edward John Fearn

      Nearly 2,000,000 people in developing countries die of diarrheal diseases -- transmitted through contaminated drinking water. Many more die from poverty/starvation.
      Apart from other issues, the ethical imperative is hardly the proliferation of vaccines, let alone one for HPV!

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    2. Sue Ieraci

      Public hospital clinician

      In reply to Laurie Willberg

      Typical distortion to throw other factors outside the discussion. Just like the tobacco-defenders saying "but people are dying of heroin addiction and alcohol!

      The development of a preventative measure for one cause of disability or death does not preclude any action targeting the others. It's also worth mentioning that Rotavirus vaccine has the potential to save many young children dying from diarrhoeal diseases faster and cheaper than the provision of universal clean water will be achieved.

      The ethical imperative is to achieve the best and most cost-effective interventions with the resources available.

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    3. Laurie Willberg

      Journalist

      In reply to Sue Ieraci

      Typical distraction to ignore common sense solutions.
      Kindly prove your claim about the Rotavirus vaccine over clean water. Just your opinion. Anything to keep adding to those pharma coffers, huh?
      The historical record shows that the advent of public water purification and public sanitation was responsible for the reduction in disease outbreaks in Western countries.
      You obviously belong to the crowd that advocated the "swat the fly" campaign that took place in New York city during the 1800's…

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    4. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Edward John Fearn

      Edward, re ‘estimates’ of cervical cancer deaths, a media release from The Royal Society of Medicine is pertinent: “Controversial vaccine trial should never have been run in India, researchers say”, 21 June 2012: http://www.rsm.ac.uk/media/pr305.php
      QUOTE
      Professor Pollock explained: “This trial has clearly raised serious concerns for the people and government of India. The aim of our study was to look at whether data on cervical cancer in the country justify the introduction of HPV vaccination…

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    5. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Elizabeth Hart

      Edward, further to my previous comment, there has been correspondence on the Mattheij et al paper, cited above, arguing about the epidemiological data, published in the current issue of the Journal of the Royal Society of Medicine (September 2012). Pollock, Brhlikova and Mattheij have responded, i.e.:
      QUOTE
      “…There are several flaws in the response from PATH. Crucially, PATH does not address the core issues of HPV vaccine efficacy and its costs. It is wrong to compare the vaccine with polio…

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    6. Edward John Fearn

      Edward John Fearn is a Friend of The Conversation.

      Hypnotherapist and Naturopath

      In reply to Elizabeth Hart

      Thanks Elizabeth

      I hadn’t come across the RSM paper before; it did raise some quite valid points. However the rates in 2010 per 100 000 were 23.5, up from 22 in 04/05. This indicates an increasing number of cases and as the rate of screening is extremely low (especially in rural areas); it doesn’t appear that cervical cancer mortality rates are likely to drop in the near future.

      Cervical cancer screening coverage, % (age and screening interval, reference)
      2.6% (All women aged 18-69 yrs screened…

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    7. Elizabeth Hart

      Independent Vaccine Investigator

      In reply to Edward John Fearn

      Edward, you acknowledge: “As yet we do not know how effective the HPV vaccine will be in the longer term…”
      You also note: “…preliminary results from HPV vaccination show a 50% decline in pre-cancerous cervical lesions in young women since the introduction of the vaccine”.
      Can you please provide a reference for that statement? I have asked Craig Sinclair of Cancer Council Victoria for a reference previously on this thread, but he has not yet responded.

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    8. Edward John Fearn

      Edward John Fearn is a Friend of The Conversation.

      Hypnotherapist and Naturopath

      In reply to Elizabeth Hart

      The information you ask for is quite easy to find online.

      http://www.abc.net.au/science/articles/2011/06/17/3245782.htm

      Yes, I do not know how effective the HPV vaccine will be in the longer term, I don't think anyone can. These early results are extremely encouraging though, and it is quite likely that this vaccine will save lives in the future.

      I do also agree that it is premature to take too much from this study and a lot of further research is still needed.

      The reference for the 90% drop in genital warts in young women and men is found here.

      http://media2.wishtv.com/_local/pdf/HPV_national_vaccinaton.pdf

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    9. Judy Wilyman

      PhD Candidate Environmental Health Policy at University of Wollongong

      In reply to Edward John Fearn

      Could Ian Frazer please answer the following questions for the Australian public?:
      1. What period of time were the 189,629 girls/women monitored for in the study he is quoting?
      2. Do the CDC and the TGA have a post-surveillance monitoring system that can establish causal relationships with the vaccine?
      3. Are parents and students in schools being informed of the ingredients in the Gardasil vaccine eg. 3x the aluminium adjuvant as other vaccines, sodium borate and polysorbate 80 etc.
      These questions are all significant to the safety of this vaccine.

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    10. Sue Ieraci

      Public hospital clinician

      In reply to Laurie Willberg

      "The historical record shows that the advent of public water purification and public sanitation was responsible for the reduction in disease outbreaks in Western countries."

      And yet, our babies and children are still hospitalised for IV rehydration every year during Rotavirus season. We have clean water, but we have rotavirus.

      Vaccination, then less rotavirus. Quite simple, really.

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  5. Steve Brown

    logged in via email @yahoo.com.au

    I wonder if somebody could address this point which Elizabeth Hart raised in the

    “When cervical cancer develops, HPV is found in almost all cases.”

    So HPV isn’t found in all cases of cervical cancer. That’s interesting isn’t it?
    http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/hpv";

    Is there a diagnostic tool of some sort which clinicians use to determine whether a woman's case of cervical cancer has been caused by the HPV or from other reasons?

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  6. Elizabeth Hart

    Independent Vaccine Investigator

    This morning The Conversation published an article titled: “No, you’re not entitled to your opinion” by Patrick Stokes, Lecturer in Philosophy at Deakin University, which generated many comments on the vicious vaccination debate: https://theconversation.edu.au/no-youre-not-entitled-to-your-opinion-9978 I made some comments on this article, including comments critical of the Health Minister, Tanya Plibersek, and the Australian Technical Advisory Group on Immunisation (ATAGI), and intended to make…

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  7. Elizabeth Hart

    Independent Vaccine Investigator

    Recently, The Australian published an ‘exclusive’ report noting that University of Wollongong PhD student Judy Wilyman had “questioned the value of the vaccine Gardasil in the fight against cervical cancer”. (“University stands by anti-vaccine student”, Rick Morton, 26 September 2012.)
    While Ms Wilyman’s views on vaccination are highly controversial, she is not alone in questioning the value of the HPV vaccine against cervical cancer. Citizens are entitled to ask well-founded questions about vaccination…

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